Coinvestigators from Mayo Clinic and the Minneapolis Veterans Affairs Health Care System (MVAHCS) collaborated with the University of Minnesota (UMN) team in designing the TACSI protocol.
The UMN maintains oversight of all study procedures, data collection, data management, and dissemination. In addition to ongoing review of protocol modifications, the UMN Institutional Review Board requires an annual continuing review process, with approval contingent upon review and approval of a study submission regarding participant accrual, withdrawal, and other study-related issues. An independent safety monitor provided additional study oversight, reviewing the annual data and safety monitoring report. Quarterly reports, including enrollment and safety updates, were submitted to the Department of Defense. This protocol was reported following the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) reporting guidelines (
The UMN Institutional Review Board approved the study protocol for the UMN and Mayo Clinic (STUDY00014886); current version 7, June 4, 2025. The MVAHCS obtained site-specific approval (1641329). All study procedures (consent, data collection, and intervention delivery) were conducted remotely with participating caregivers residing in the United States. Based on the caregiver’s preference, consent was completed either electronically via the secure survey platform, Qualtrics, via telephone, or mailed with telephone consent.
All electronic data (eg, administrative tracking logs, survey data, and coaches’ notes) from potential and enrolled participants were maintained in secure environments (ie, Qualtrics, secure project folder, and Box). Participant data and their identifying information were kept in separate files. Links to identifiable data will be destroyed 2‐3 years after data collection is complete. All data on the team’s computers was encrypted and protected by strong passwords only accessible to the UMN research team. The team used Duo 2-step verification to access VPN/Secure servers. Any hard copy forms were stored in a file cabinet in an office that was locked at all times. Interview audio recordings were deleted from secure recording devices after they were uploaded to Box and a secure server. Transcripts were created by a HIPAA (Health Insurance Portability and Accountability Act)-compliant organization and deidentified.
Upon completion of the study, caregivers were compensated for their participation. Caregivers received US $25 for each completed survey (T0, T1, and T2), for a total of up to US $75. An additional US $25 was provided to those caregivers in the treatment group who completed a final semistructured interview. Separate compensation for completion of the treatment receipt checklist (TRC) was not provided.
Prior to initiating this pilot study of TACSI, the study team developed and implemented TACSI for 15 family members of persons with a dual diagnosis of TBI & AD/ADRD to assess the feasibility, acceptability, and appropriateness of TACSI over a 3-month period (phase I). The results of the pilot study supported the feasibility, acceptability, and appropriateness of TACSI [
In this study (phase II), the specific aims were to use a pilot RCT design with 80 caregivers to evaluate the implementation and preliminary efficacy of a refined version of TACSI over a 6-month period. Specifically, we sought to evaluate the impact of TACSI on primary subjective stressors, including caregiver perceived burden, relationship satisfaction, ideology, and mastery (primary outcomes), primary objective stressors (assistance with ADL/instrumental activities of daily living), and well-being, resource usage, and coping strategies.
This embedded experimental mixed methods study used a pilot RCT design to determine the feasibility and performance of TACSI with 80 caregivers of persons with TBI-ADRD. The mixed methods approach integrated elements of quantitative and qualitative data collection at multiple time points throughout the study for a more robust analysis, enriching our understanding of the caregiver experience in comparison to solely collecting qualitative or quantitative data (
Inclusion of qualitative data provides pertinent context for interpretation of quantitative results and rich insight into the intervention’s mechanisms of benefit [
Mixed methods design. TACSI: TBI (traumatic brain injury)-AD/ADRD (Alzheimer disease and related dementias) caregiver support intervention.
Study survey administration was offered via web or mail to be completed in hard copy. Two trained coaches from the UMN delivered TACSI to caregivers in the treatment group via secure video conferencing (ie, Zoom) or telephone. Finally, caregivers selected to participate in a semistructured interview could complete the interview by videoconference or telephone.
Eligible caregivers were those who (1) cared for someone with a dual diagnosis of progressive cognitive decline (eg, AD/ADRD) and history of a TBI, (2) provided the most help to the care recipient (or shared the role equally), (3) were willing to participate in the TACSI evaluation, (4) spoke English, (5) were 21 y or older, (6) were not currently participating in other 1:1 psychosocial consultation specific to caregiving, and (7) resided in the United States. Caregivers were excluded if they endorsed a new or worsening mental health condition for which they were not receiving ongoing treatment. If using a psychotropic medication, caregivers needed to have been on a stable dose for at least 3 months prior to study enrollment.
Based on the target population of those caring for patients with a dual diagnosis of TBI and AD/ADRD, the MVAHCS and Mayo Clinic generated internal data requests for patient records using
The 2 health care systems (HCSs) were responsible for making initial contact to describe the study. The UMN study team met weekly with staff from Mayo Clinic and MVAHCS throughout study recruitment. Specifics of the HCS contact protocol slightly varied by site.
Patients and caregivers affiliated with the MVAHCS received contacts similarly. The MVAHCS required a letter or encrypted email to be sent prior to study-related follow-up telephone calls by the HCS. Contacts could opt out of further study-related communication. Since the MVAHCS could not share contact information for interested caregivers directly with the UMN study team, the MVAHCS protocol required interested contacts to alert the study team directly via a web-based form or a call (by the caregiver or by transferring their call to the study line). To facilitate recruitment, staff at either HCS could provide a phone transfer to the UMN study telephone number for interested contacts to discuss screening with the research team.
HCS recruitment diagram. HCS: health care system. *Applies to Mayo Sites Only; ** Applies to VA (Veterans Affairs) site only.
The majority of participants were recruited through the MVAHCS or Mayo Clinic. In addition to HCS recruitment solely based on diagnosis codes, caregivers of someone with a dual diagnosis of TBI and AD/ADRD could express interest in participating in this research study when recruited by MVAHCS or through study postings on ClinicalTrials.gov and StudyFinder. Interested caregivers could call or email the study team directly or complete a web-based permission to contact form to obtain more information about the study.
Each potential participant completed a telephone-based screening procedure to determine eligibility. Only caregivers who were not referred from the MVAHCS or Mayo Clinic were required to answer eligibility questions related to their care recipient’s diagnoses to ensure the presence of a dual diagnosis of TBI-AD/ADRD. If eligible, the staff member described the study activities and proceeded to the consent procedures.
Study enrollment began in June 2023. Target enrollment (n=80) was reached in November 2024. Final data collection was completed in June 2025 (
Following consenting procedures, participants were administered a baseline survey; baseline surveys included demographic items for the participating caregiver and the person they care for, as well as a battery of quantitative survey measures.
TACSI study flowchart. SSI: semistructured interviews; TACSI: TBI (traumatic brain injury)-AD/ADRD (Alzheimer disease and related dementias) caregiver support intervention.
SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) timeline of enrollment, intervention, and measures.
| Activity or assessment | Prestudy | Baseline survey (t0) | Randomization | Follow-up survey (t1) 3-months post- t0 completion | Follow-up survey (t2) 3-months post-t1 completion | End of study |
| Eligibility screen | ✓ | |||||
| Informed Consent | ✓ | |||||
| Outcome measures | ||||||
| Modified Caregiver Appraisal Scale [ | ✓ | ✓ | ✓ | |||
| Psychological Distress: The Center for Epidemiological Studies-Depression Scale [ | ✓ | ✓ | ✓ | |||
| TBI-CareQOL | ✓ | ✓ | ✓ | |||
| TBI-CareQOL Feelings of Loss – Person with TBI – Short Form 6a [ | ✓ | ✓ | ✓ | |||
| TBI-CareQOL Feeling Trapped – Short Form 6a [ | ✓ | ✓ | ✓ | |||
| TBI-CareQOL Caregiver-Specific Anxiety – Short Form 6a [ | ✓ | ✓ | ✓ | |||
| TBI-CareQOL Caregiver Strain – Short Form 6a [ | ✓ | ✓ | ✓ | |||
| TBI-CareQOL Caregiver Vigilance – Short Form 6a [ | ✓ | ✓ | ✓ | |||
| TBI-CareQOL Emotional Suppression – Short Form 6a [ | ✓ | ✓ | ✓ | |||
| TBI-CareQOL Family Disruption – Short Form 3a [ | ✓ | ✓ | ✓ | ✓ | ||
| Health Services Service Use | ✓ | ✓ | ✓ | |||
| Community-Based Services Use [ | ✓ | ✓ | ✓ | |||
| COPE [ | ✓ | ✓ | ✓ | |||
| Interpersonal Support Evaluation List [ | ✓ | ✓ | ✓ | |||
| Caregiver Self-Efficacy Scale [ | ✓ | ✓ | ✓ | |||
| Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) [ | ✓ | ✓ | ✓ | |||
| Revised-Memory and Behavior Checklist [ | ✓ | ✓ | ✓ | |||
| Intervention | ||||||
| Caregiver support intervention | ✓ | |||||
| Usual care control assignment | ✓ | |||||
| Treatment Receipt Checklist | Treatment group only | Treatment group only | ||||
| Semistructured Interview | Select treatment group participants |
aMore information about the outcome measures can be found in the
bOmit if bereaved.
cTBI-CareQOL: Traumatic Brain Injury Caregiver Quality of Life.
dOmit if previously completed post-bereavement.
eInterview questions can be found in the
After baseline survey completion, participating caregivers were randomly assigned on a 1:1 basis to participate in either (1) the TACSI program treatment group or (2) the usual care control group (the latter continued routine care through their HCS). The random assignment schedule was created digitally by a staff member involved in the study solely for this task, via Research Randomizer. Participants had equal chances of being assigned to either the treatment or control group. The assignment schedule was input into a series of sequenced envelopes to be opened in order at the time of randomization (following a participant’s baseline survey completion).
The study coordinator informed participants about the results of their randomization to either the TACSI treatment group or the usual care control group via phone, email, or both. Coordinators also alerted the TACSI study coaches, who divided the participant caseload based on workload and availability. Those in the control group were given the opportunity to request resources or referrals during their randomization notification and as a part of the survey completion thank you procedures in order to provide support and bolster retention.
After randomization, the assigned TACSI coach contacted the caregiver assigned to the treatment group to offer introductory information, including a description of the semistructured program (eg, design, length, and frequency of sessions) and to determine caregiver preferences for participation (eg, modality of delivery).
The TACSI program is a 6-session semistructured psychosocial and psychoeducational program, developed to increase caregiving skills and strategies and provide support to improve mood, reduce stress, and increase caregiver self-efficacy. TACSI provides individual coaching and ad hoc support to caregivers. Intervention sessions are conducted on a weekly basis, as schedules permit. Sessions typically last from 45 minutes to an hour and a half, depending on discussion needs and participant preferences. Sessions are held remotely via telephone or secure video conferencing (ie, Zoom) based on participant requests.
The initial TACSI session includes an informal interview to build rapport and allow the coach to learn about the caregiver and care recipient, identifying critical stressors and priorities for the intervention. All subsequent sessions include a brief check-in for caregivers to share updates of their previous week and ascertain the most relevant focus of the session, followed by a discussion of pertinent module content. The conclusion of each session may include discussion of self-care plans for the upcoming week, determining goals or homework, and scheduling the next session, if applicable. The order of delivery of TACSI modules 2 through 5 is intentionally flexible to respond to the priorities and needs of the participant. The sixth session serves to discuss any unexplored intervention content, review previously presented material, and address any remaining caregiver questions.
A TACSI intervention manual provided an overarching structure and guide to facilitate the coach’s intervention delivery. The semistructured nature of the program allows coaches the flexibility to tailor the intervention based on the caregiver’s needs and priorities. All topics in the manual are offered during the intervention, but the depth of exploration, if any, is determined by the caregiver. Further, tailoring and personalization of the session content and focus are emphasized by the caregiver guiding the selection of topics to discuss and deciding when to discuss them during the intervention.
TBI-AD/ADRD
| Dimension | Options |
| Method of caregiver/coach contact | Telephone Secure video conferencing (ie, Zoom) |
| Intervention materials | |
| Delivery location | Remote delivery via: Telephone Secure video conference calls |
| Schedule: duration and intensity | Session types: Six weekly TACSI sessions (approximately 60 minutes each) Ad hoc consultation as needed (approximately 45 minutes) Participants could voluntarily withdraw from intervention at any time. Time needed for documentation (approximately 30 minutes post-session): Session dates Session length Number of ad hoc sessions Length of ad hoc sessions Session notes |
| Scripting/tailoring of intervention | Semistructured intervention based on treatment manual General guidelines and some language provided; elaboration and discussion encouraged Topics specified; coach tailoring of which topics to discuss and when, based on caregiver priorities and needs Personalization emphasized based on caregiver and care recipient background, experiences, and abilities |
| Sensitivity to participant characteristics | Personalization of session content/topics (see Scripting/Tailoring of Intervention) Language preferences, literacy, visual supplements/augmented communication have not been incorporated or requested by participants |
| Interventionist qualifications, training, and experience | Bachelor’s degree or higher Experience working with individuals with dementia and their caregivers Training relevant to understanding the treatment manual and ongoing support for accurately implementing the intervention: Thorough step-by-step review of the treatment manual Regular coaching meetings (problem-solve questions and concerns, share available resources, etc) Role play intervention material (Consider having trainees shadow/listen to sessions or mentors observe and provide feedback on trainee’s sessions) Competence in remote intervention delivery Ability to build and maintain rapport |
| Adaptability: extent to which intervention can be modified | What: Ad-hoc sessions Session length Caregiver location Mode of delivery (telephone vs secure video conference) Session Content When: Any time while enrolled in study Why: Participant request Participant availability Participant preference Coach judgment |
| Treatment implementation: Delivery: documentation of interventionist compliance to intended treatment and modifications Receipt: extent to which processes are implemented by participant and goals are met Enactment: extent to which knowledge and skills acquired during treatment are applied in real-world settings outside of treatment | Documentation: Number and duration of sessions Content delivered Treatment receipt checklist survey responses Participant self-report during sessions Coach appraisal of participant understanding, acquired skills, caregiving self-efficacy, engagement, and use of supports (recorded in coaching notes) Semistructured interviews conducted with purposively sampled primary caregivers at conclusion of participation |
| Content and goals | |
Psychoeducation/didactic instruction Personalized resource identification and provision Facilitation of family and social support and involvement Effective communication and conflict resolution skills, including advocacy Skill-building techniques and problem-solving techniques Stress management techniques and relaxation exercises Processing and emotional support, including for guilt and grief Active coping strategies | |
Improved knowledge of dementia Improved engagement with care recipient, family, and health care team Increased awareness of resources and supports Improved social and family support Improved communication and conflict resolution skills Increased problem-solving skills Increased prioritization and engagement in self-care and stress management Increased caregiving self-efficacy Increased caregiving competence | |
aTBI: traumatic brain injury; AD/ADRD: Alzheimer disease and related dementias.
In each session, coaches aim to establish and maintain a therapeutic rapport with the caregiver while providing a safe, neutral third-party environment to identify, explore, and discuss their stressors. Coaches engage in thoughtful conversation, providing psychoeducation and resources to support each caregiver. They provide individualized constructive guidance and feedback to help caregivers address their unique needs, respond to challenging situations, and use newly learned skills. Coaches also have the flexibility to tailor the length of sessions and to include topics outside of the manual to meet the participant’s needs. After each meeting, coaches record session notes, detailing key caregiving issues, relevant family dynamics, the caregiver’s reaction to the session, and anticipated content for the subsequent session.
TACSI is a multicomponent program combining psychosocial support with psychoeducational and skills training. Multicomponent interventions have been associated with improving caregiving outcomes [
Modifications for TACSI included adding TBI-specific content, such as education on how a TBI may affect the brain and behavior, managing TBI-related concerns, and resources for caring for individuals with TBI. The TACSI program also featured an increased number of approaches for managing negative or anxious thoughts and additional new topics such as how to work effectively with the care recipient’s health care team, how to ask for and accept help, and how to navigate changes in partner intimacy. Additionally, coinvestigator JF, an expert on TBI caregiving, reviewed and edited the intervention manual, providing feedback and recommended resources.
TBI-AD/ADRD
| Session | Content |
| Session 1: | Module 1 (caregiver interview): to explore the caregiver’s journey (eg, individuals involved, roles, stressors, strengths/weaknesses of care, etc) to guide the intervention. |
| Modules 2-5: | Module 2 (increasing understanding of dementia and traumatic brain injury and building awareness of supports and services): (1) to provide psychoeducation TBO and dementia, as well as impact on daily life (brain, cognition, personality, and behavior), (2) to discuss local/national supports tailored to individual participants’ needs, and (3) to introduce/set SMART Module 3 (supporting emotional health and well-being): (1) to explore experiences of guilt and grief and (2) to increase the understanding of stress and coping strategies. Module 4 (encouraging realistic expectations and adjusting to lifestyle changes): (1) to explore roles and expectations and (2) to share activity ideas. Module 5 (effectively working with a health care team/enhancing communication): (1) to review tips for navigating and partnering with the health care team and (2) to discuss conflict resolution. |
| Session 6: | Module 6 (review of intervention topics and discussion of wrap-up questions): (1) to wrap up/highlight any intervention content and (2) to review wrap-up questions assessing caregiver adjustment, strengths, and challenges. |
aTBI: traumatic brain injury; AD/ADRD: Alzheimer disease and related dementias.
bSMART: Specific, Measurable, Achievable, Relevant, Time-Bound.
Intervention sessions focus on exploring the participant’s caregiving experience, including the supports and strategies they currently use, while determining and subsequently sharing skills, approaches, and new information they likely will benefit from acquiring. A key objective for each session is to build the caregiver’s resources in order to alleviate primary subjective stressors, increase caregiver confidence, and enhance awareness and use of informal and formal supports and services. Intervention content and coaching strategies were purposefully selected to positively impact primary (caregiver perceived burden, relationship satisfaction, ideology, and mastery) and secondary outcomes (table of measures is provided in
TBI (traumatic brain injury)-AD/ADRD (Alzheimer disease and related dementias) caregiver support intervention (TACSI) map. AD: Alzheimer disease.
To increase understanding of AD/ADRD and TBI, coaches share how TBI and dementia affect the brain and how that may impact behavior, personality, and cognition. This education provides an explanation and foundation for the caregiver to understand why the relative may be functioning as they are and how they may be impacted in the future. Learning that their care recipient’s behavior is not an intentional choice, but a result of the injury or disease process, can help reduce the annoyance some caregivers may experience. It also helps them to have appropriate expectations and to make plans for the future. In addition, the intervention shares approaches that help to prevent and better manage frustrating behavior (eg, aggression, wandering, hygiene avoidance). Education also focuses on processing and addressing uncomfortable role changes that the caregiver may be experiencing, including adjusting to new responsibilities and changes in spousal intimacy.
The intervention aimed to help improve mood and manage stressors. Exploration of the caregiver’s experiences with guilt and grief sought to help identify sources of negativity and subsequently, process, validate, normalize, and reframe those negative emotions. Stressors were identified, including those related to caregiving, as well as outside sources of stress. Stress management techniques, including relaxation exercises and problem-solving strategies, such as breaking a larger problem into smaller tasks and setting specific, measurable, achievable, relevant, and time-bound goals, were explored. The caregiver’s experience with loneliness and social isolation was explored, along with the importance of self-care and social engagement.
Coaches focused on providing a range of communication skills and strategies for caregivers to use with their care recipients, families, health care teams, and others. Through psychoeducation on the tenets of effective communication and the sharing of conflict resolution strategies, the intervention aims to help caregivers convey their perspective, gain understanding and support from others, and advocate for their care recipient. Coaches also offer approaches on how to best engage with a health care team, adapted from the Health Resources and Services Administration’s “Working with a Healthcare Team” module [
Caregivers learn about the local and national supports and services that can meet their unique needs. Provision of these personalized local and national formal supports is complemented by the identification of sources of informal support, such as family, friends, and neighbors. Once these informal sources of support are identified, coaches process caregiver reservations about asking for assistance, provide guidance, and encourage caregivers to ask for and accept offers of help and respite.
Ad hoc sessions, delivered via telephone, secure web conferencing, or email, were available at any time between sessions and following intervention completion. Caregivers could schedule a standing ad hoc session or request impromptu ad hoc coaching. Ad hoc sessions and email consultations were unstructured and designed to address any caregiver concerns in a timely manner.
The program is designed to be delivered by a qualified coach based on education or training. Recommended qualifications include: (1) a Bachelor’s degree or higher in a health or wellness-related field; (2) relevant experience working with people with memory loss or their caregivers; (3) experience or proficiency in remote intervention delivery, particularly having the ability to establish rapport without being in person; and (4) completion of TACSI training based on the intervention manual. See
TACSI coaches were 2 doctorally educated staff (DNP and PhD in clinical psychology). Both have personal and professional experience with individuals with dementia and their caregivers, as well as experience with remote intervention delivery. The coaches worked together previously on ADRD caregiving studies. Similar procedures were used in this study as in the previous intervention studies.
The coach-developed (RB) intervention includes a manual that specifies the procedures for delivering the intervention and details module content. The manual serves as a guide on intervention structure, delivery processes, and session content. Coach training consisted of a thorough step-by-step review of the treatment manual, including discussion of appropriate question prompts, how to start topic discussions, and how to tailor the content to the individual participant. Coaches meet regularly to discuss the intervention, problem-solve any concerns, and share information and newly discovered resources. Coinvestigator JF, a MVAHCS staff psychologist, was present at weekly meetings throughout study recruitment and was available to confer with coaches on any issues as needed.
Data collection for both treatment and control groups was conducted via surveys. Additional data were collected from treatment group caregivers via TRCs and semistructured interviews.
Caregivers received a baseline survey collecting information on sociodemographics, context of care, and outcome measures. The baseline survey contained sociodemographic measures for both the caregiver and care recipient (date of birth, gender, racial background, marital status, education level, and household income). Context of care variables, such as geographic location, caregiver work status, health conditions, and relationship to care recipient were assessed. Additional variables included year and severity/type of TBI and AD/ADRD diagnoses with concurrent symptoms, care recipient Veteran and Medicaid status, and living arrangement.
Two follow-up surveys were administered by a research assistant blinded to participant group assignment from randomization through the end of analysis. The first follow-up (T1) was administered at 3 months post completion of the baseline survey; the second follow-up was administered 3 months after completion of the 3-month survey (T2). If a care recipient passed away during the study, modified bereavement surveys were administered at follow-up.
Three options for completing surveys were offered: online via Qualtrics, a mailed survey, or over the phone with study staff. The specific measures selected for assessment have strong psychometric properties;
Adverse events were defined prior to the onset of the study, and standardized procedures were determined to address these events, if encountered. At the 3 and 6 month follow-up timepoints, participants were asked: “In the last three months, since your last survey, was there any new or worsening health problem that caused you to be unable to perform your daily routine (ie, not go to work or volunteer), seek medical care (ie, go see your doctor, go to the ER or hospital), or take a new medication?” Those medical events were documented as adverse events. In addition, during each intervention session, coaches inquired into and addressed participant health and other concerns, as applicable.
Staff provided up to 4 reminders to complete each survey via phone or email. If a follow-up survey was not completed, subsequent surveys were still sent unless the participant withdrew from the study. Staff provided a thank-you phone call or email after completion of each survey.
Within 2 weeks of the completion of their follow-up surveys (T1, T2), treatment group caregivers were sent an additional survey by an unblinded staff member to evaluate treatment receipt via a brief TRC, as well as assess the acceptability, appropriateness, and feasibility of the intervention. Unblinded staff provided reminders to complete the TRCs; thank you emails or calls were completed following survey completion.
The TRC is a 13-item survey evaluating participant receipt of various components of the intervention using 12 Likert scale items (1=strongly disagree to 5=strongly agree, with an option for not applicable/does not apply to me). An open-ended question inquiries about how TACSI was or was not helpful (Wilson et al [
Acceptability, appropriateness, and feasibility of the intervention were evaluated using the acceptability of intervention measure (AIM), the intervention appropriateness measure (IAM), and the feasibility of intervention measure (FIM) [
If the care recipient passed away during the study, the participating caregiver was offered condolences by the staff. Pending their willingness to continue the study, these caregivers were administered modified bereavement surveys at follow-up. If the caregiver was in the treatment group, they no longer participated in standard TACSI sessions. However, the interventionist offered optional ad hoc sessions focused on the participant’s needs, integrating TACSI content only if relevant. Depending on the number of study time points remaining, either one or two bereavement surveys would be administered, both omitting measures no longer applicable, as shown in
In the case of a care recipient’s nursing home admission, the caregiver could continue study involvement (TACSI intervention and routine follow-up surveys) as usual.
Twenty participants in the treatment group were purposely selected to participate in an audio-recorded semistructured interview to provide qualitative data regarding the TACSI program. Staff selected participants who rated TACSI with higher and lower average scores on the TRC and measures assessing the intervention’s appropriateness, acceptability, and feasibility (see above). Additionally, as the sample allowed, the study team made an effort to select participants with varied characteristics: relationship to care recipient (partner, adult child), severity of condition (TBI-AD/ADRD), and racial/ethnic identity. Participants could complete the semistructured interview via phone or secure video conferencing (Zoom).
Throughout each caregiver’s time in the study, coaches documented any participant contact for treatment and control participants: dates, method of contact, length of contact, and general topics of discussion. Session notes were also completed by coaches, documenting key issues, family dynamics, participant response or engagement with session content, and plans for the next session’s content.
Quantitative analysis will include descriptive statistics, such as frequency tables and means, to describe sample characteristics and TBI-AD/ADRD caregiver outcomes. Enrollment and recruitment data, such as the number of contacts or referrals by site, reasons for exclusion, and retention, will be summarized. Distribution/normality and missing data will also be examined.
The number of TBI-AD/ADRD caregivers enrolled to address the study hypotheses (n=80) was determined using power analysis procedures that relied on Wänström’s Monte Carlo simulations [
We will calculate means and create frequency tables to evaluate AIM, IAM, and FIM measures and TRC at T1 and T2. We will determine if 80% of treatment caregivers found the intervention appropriate, feasible, and acceptable at the 2 follow-up timepoints (T1 and T2).
Post hoc analyses will also be conducted. Specifically, to examine the effects of TACSI use on changes in primary subjective stress and caregiver well-being, intervention session data regarding variations in use of TACSI, such as frequency and duration of counseling sessions, will also be included in the growth curve models.
The qualitative analysis will use reflexive thematic content analytic techniques as described by Morse, Moser, and others [
The mixed methods analysis aims to provide empirical context for the participants’ perceptions of TACSI. A sequential mixed methods sampling approach was used in selecting treatment participants for the semistructured interviews. This will enable research staff to better understand participants’ perceptions of TACSI’s usefulness while also linking qualitatively derived themes with the outcome data. Specifically, the empirical outcome data will be sorted by qualitative themes that appeared across the 2 subgroups of the semistructured interview sample (those who rated TACSI as highly acceptable, feasible, and useful in the TRCs vs those who rated TACSI poorly on the same measures). This mixed methods approach will allow us to determine if certain themes appear more often for one subgroup than the other subgroup, or if the subgroups use TACSI recommendations differently.
To facilitate data preservation and sharing following project completion, the study protocol includes a plan to deposit quantitative survey study data into a centralized repository. Pending regulatory recommendations and availability at the time of post-study submission, the team has focused data preparation efforts on procedures developed by the Federal Interagency Traumatic Brain Injury Research Informatics System, developed by the National Institute of Health in collaboration with the Department of Defense. Alternatively, the Data Repository for University of Minnesota (a data repository located at UMN) or a similar resource will be used.
Results of this study will be shared with participants via a one-page summary and posted to the team’s website. The team will publish the results in academic journals and potentially present at gerontological conferences and community sites, including at TBI and dementia-focused organizations.