Chronic pain (CP), or pain that persists for more than 3 months, is common in the United States, costly to the health care system, and difficult to treat [1]. CP becomes more prevalent with increasing age, affecting 25-50% of community-dwelling older adults [2] and over 80% of nursing home residents [3]. Cognitive decline (CD) [4], defined as subjective (ie, self-report only) or objective (ie, confirmed by formal testing) decreases in cognitive performance that surpass normal aging [2], is a growing public health priority as life expectancy increases. There is a bidirectional relationship between CP and CD [5]. Older adults with CP are twice as likely to endorse CD [4] and are at greater risk for neurodegeneration [6], which in turn exacerbates perceptions of CP [7]. CP [8,9] and CD [10] exacerbate each other, placing individuals on a disability spiral of worsened physical, emotional, and cognitive functioning [11,12].

Unfortunately, current treatments are inadequate for addressing the CP-CD comorbidity among older adults [4,13]. CP and CD are often initially treated with medications, which are limited in efficacy [14] (eg, lack cognitive benefits) [15]; increase the risk of adverse events, such as falls [16]; and are associated with harmful side effects that can worsen CD [17]. Nonpharmacological interventions for CP that teach adaptive coping skills can improve physical, emotional, and social functioning [18] but overlook the needs of older adults with CD. Walking-based mind-body activity programs may be feasible and effective in addressing the CP-CD comorbidity among older adults [19-22].

We are iteratively developing the first mind-body activity program to address the CP-CD comorbidity among older adults using the National Institute on Aging (NIA) Stage Model [23], which emphasizes early refinement before efficacy testing (Figure 1). First, we developed Active Brains (AB) and Active Brains-Fitbit (AB-F) using qualitative data from patient focus groups (stage 1A) [13]. Both programs teach identical mind-body skills to address the CP-CD comorbidity and increase participants’ step count, but AB-F participants set individualized quota-based step goals [21] reinforced by a Fitbit [24]. In a nonrandomized open pilot trial (stage 1B), both programs similarly displayed (1) preliminary feasibility and acceptability when delivered in person; (2) within-group improvements for pain intensity, pain-specific coping, physical function, and cognitive function; and (3) high participant satisfaction [13]. Qualitative individual exit interviews assisted in further optimizing the program components and study methodology [13]. Participants in the Fitbit group found the device useful for monitoring their progress in real time, enhancing motivation, and reinforcing individualized goals, which align with positive perspectives of technology to modify health behaviors [25,26].

These findings informed 2 main decisions in the preparation for a future stage II efficacy trial. First, because AB and AB-F performed similarly with regard to both feasibility benchmarks and preliminary effects and participants in the AB-F group found using a Fitbit to monitor and safely increase step count beneficial, our next stage 1B trial will be a single-blind pilot randomized controlled trial (RCT) of AB-F versus an attention placebo control (health enhancement program [HEP]) [27]. Second, due to COVID-19, many of the exit interviews after our in-person trial were conducted virtually [28], and participants generally preferred this remote modality. Qualitative results from our previous work [29] highlighted participants’ interest in live video delivery to overcome barriers to in-person attendance commonly experienced by older patients, such as lack of flexible scheduling, difficulty coordinating transportation, and travel costs [30]. Further, a growing body of research shows that older adults can effectively use technology [31], including live video [32] and wearable devices. Our virtual adaptations to mind-body interventions for patients with neurofibromatosis [33,34], stroke, and CP [35] suggest that older adults with CP and CD [13] may also be amenable to AB-F delivered via live video. The findings will inform a subsequent pilot RCT to test feasibility benchmarks of the ability to randomize individuals to the intervention (AB-F) or control (HEP) as well as deliver the programs and conduct all study procedures virtually.

Here, we describe live video adaptations to study procedures and delivery of AB-F versus HEP in older adults with CP and CD within a single-blind RCT. We hypothesize that AB-F delivered via live video would meet a priori feasibility (recruitment, quantitative measures, and adherence), acceptability, credibility, expectancy, and satisfaction benchmarks similar to our in-person trial. Patients’ in-depth perceptions of technology will be assessed, including virtual assessment and intervention delivery via exit interview focus groups with participants after the programs as well as through a post intervention self-report survey. The results will inform a subsequent efficacy RCT (stage II) of AB-F versus HEP, both delivered in group via live video. The following hypotheses will be tested: (1) AB-F is superior to HEP in improving objective, performance-based, and self-reported measures of physical, cognitive, and emotional function outcomes; (2) AB-F–related improvements will sustain over time; and (3) program targets (eg, mindfulness and coping) and relevant clinical and demographic variables will serve as mediators and moderators of improvement in outcomes.

This single-blind feasibility RCT of AB-F versus a time- and dose-matched educational control (HEP) in older adults with heterogeneous CP and CD is being conducted at a large academic medical center in the Northeastern United States. Our institutional review board (IRB) approved this study (#2018P002152). Figure 2 presents a diagram of the study design and timeline of the procedures outlined below.

Textboxes 1 and 2 present the criteria and rationale for study inclusion and exclusion, respectively. These eligibility criteria are consistent with similar mind-body trials with patients with CP [18,35] and our earlier program development work with this population [13,29]. The criteria are meant to be as inclusive as possible by allowing individuals with any type of musculoskeletal CP and any type of subjective or objective CD to participate to maximize generalizability consistent with NIA guidelines [23].

Participant recruitment and screening was initiated in August 2020. To facilitate local recruitment of older adults with comorbid CP and CD, we established interdisciplinary partnerships with the Memory Disorders Division, Center for Pain Medicine, the Psychological Assessment Center, and the Osher Center for Integrative Medicine Clinical Program within our institution. Participants may also present to hospital-affiliated or regional medical practices that treat CP or CD and meet the study criteria. Our IRB-approved recruitment flyer is distributed to physicians at these recruitment sites and public online groups for CD and/or CP (eg, open forums for CD and Facebook groups for individuals with CD and their loved ones). Use of virtual recruitment and enrollment as well as live video intervention delivery allows geographically diverse older adults to participate in the study.

A trained research assistant with experience in coordinating mind-body intervention trials for CP recruits and screens participants by phone from a private location. The research assistant provides study details to interested participants and screens for eligibility via phone. Those who express interest and wish to participate in the study may opt to review the consent form briefly with a member of the study staff via phone during the initial screening conversation. The research assistant makes 3 contact attempts before discontinuing and maintains an updated log of all screening attempts for study data reports. The principal investigator, a licensed clinical health psychologist with expertise in older adults, mind-body interventions, CP, and CD, reviews all cases before enrollment to confirm eligibility. We have successfully used this strategy in prior intervention development trials conducted remotely [39,40].

Our goal was to enroll and randomize up to 10 participants for each of the 2 rounds in this pilot RCT (N=20) and to deliver the programs in small groups of 5-6 participants, consistent with guidelines for conducting virtual group interventions [41,42]. The research assistant coordinates with eligible and interested participants via phone to select an appropriate time for group meetings based on the availability of the majority of participants. The research assistant emails participants the consent form and asks them to return an electronically signed copy within 48 hours. If needed, the research assistant contacts participants to answer remaining questions about the consent form (ie, how to electronically sign). Participants are considered enrolled when they have returned the signed informed consent form via email, are randomized, and attend at least one session. Participants earn US $30 for each assessment (baseline and post intervention, US $60 in total), US $10 for each intervention session (8 sessions, US $80 in total) and homework (AB-F only), and US $30 for the exit focus group (US $170 in total).

Randomization occurs after consent but before the baseline assessment to allow time for mailing the Fitbit to those in AB-F. Randomization follows a block design (blocks of 12) to ensure that equal numbers of patients are split into the AB-F or HEP groups. To maintain single-arm blinding, the study staff refer to the AB-F and HEP as AB1 and AB2, respectively. After randomization, the research assistant sends the Zoom appointment information for group sessions for the 10 weeks of the study, including the following: (1) the baseline assessment to practice Zoom, receive accelerometer instructions, and complete self-reports via Research Electronic Data Capture (REDCap); (2) 8 intervention sessions; and (3) post intervention to readminister self-reports and review accelerometer instructions. The research assistant also mails each participant a package that contains a folder with: (1) a welcome letter from the principal investigator (AV), (2) testing materials for the Montreal Cognitive Assessment (MoCA) [43] and accelerometer (wear-time log, instructional document, and reminder card), and (3) a prepaid envelope to mail the accelerometer back to the study staff. The AB-F group receives an additional sealed envelope with a Fitbit, charger, wall-plug, instructions on the device, and log-in information. AB-F participants are asked to not open that envelop until their Fitbit pairing session, and all participants are notified of their group assignment after all baseline assessments are complete.

Prior research shows that older adults face several barriers to adopting new technology, including decreased learning and memory capacity, lower self-efficacy, and decline in vision and motor skills [44-47]. To optimize feasibility, acceptability, and adherence, we follow guidelines for facilitating older adults’ use of technology, such as leveraging social support [48], providing reassurance, and linking to personal relevance [49,50], and allowing time for self-directed learning and experimentation to develop confidence [51]. We use additional strategies to further promote familiarity with the specific technologies used in this virtual RCT. First, the research assistant gauges individualized levels of technical support needed by asking participants: (1) whether they have used Zoom before, (2) which laptop and smartphone devices they own, (3) if they have an in-person support who can help them troubleshoot, and (4) whether they prefer an online or physical copy of the program manual. Second, we instruct participants to contact study staff for technological assistance at any time. Third, the study clinician and research assistant collaborate via text messaging to provide real-time technical support during session appointments (eg, connection or audio/video issues). Fourth, the research assistant immediately contacts participants who missed a group session to schedule a make-up with the study clinician to prevent missed material. Fifth, participants in both groups may consent to electronic reminders (phone calls, text messages, or email based on preference) to increase session attendance and adherence to technology. Text messages are sent once a day during the study, and participants may opt out at any point. Sixth, the study clinician allots up to 10 min at the start of each session to overcome technological barriers that emerge. We describe specific live video adaptations to our procedures using the technologies below.

The 8 treatment and 2 assessment sessions (all 90 min) are delivered to both treatment arms concurrently via Zoom over a total of 10 weeks. Participants can attend the online group sessions from their home or another private place with a personal computer. Both treatment arms are delivered by trained clinicians under the direct supervision of health psychologists with expertise in mind-body and walking interventions, geropsychology, and CP. We follow the National Institutes of Health recommendations [60] and our previously developed clinical adherence protocol to assess treatment fidelity of both programs [39]. The clinicians complete fidelity checklists after each session and undergo weekly supervision to reinforce protocol adherence. We will confirm fidelity to both programs by independently coding adherence in a random sample (10%) of the audio recorded sessions. Table 1 outlines the 8 AB-F and HEP sessions.

Table 2 contains the a priori set benchmarks and criteria that align with our prior in-person trial [29] and similar feasibility pilot studies [35,39,61]. We will assess the feasibility (recruitment, quantitative measures, and adherence), acceptability, credibility, expectancy, and satisfaction of both programs delivered virtually.

We selected quantitative measures informed by the CP and CD literature and by our prior mixed methods study [13,29], which provided preliminary evidence for signals of improvement in this population. Following the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials criteria [66], we measured physical function comprehensively with an objective measure (accelerometer step count), a performance-based measure (6MWT using Timed Walk), and several self-report measures (questionnaires). Textbox 3 provides brief descriptions of all quantitative assessments.

All participants will have the opportunity during the post intervention REDCap survey to provide feedback on the program via Likert questionnaires and open responses on the study technology (Zoom, virtual MoCA, and Timed Walk), Fitbit (AB-F group only), procedures, treatment manuals, support from study staff, and expectations of the program. In addition, we will conduct a brief virtual exit interview focus group (30 min) via Zoom during the post intervention assessments with both AB-F and HEP participants to further explore the impressions of the program and inform the next trial. Given prior optimization of the program via qualitative methods, the exit focus groups will gather impressions about the virtual delivery of skills and the technological aspects of the program. We will follow our procedures for conducting virtual focus groups [83] and guidelines for collecting qualitative data [84,85].

Consistent with guidelines for early feasibility studies [86,87] and the NIA Stage Model, our mixed method analysis will not assess efficacy [23]. However, we will evaluate whether this virtual pilot RCT achieved similar feasibility and acceptability to our prior in-person trial [29]. Our target sample size is appropriate for exploring feasibility and outcomes for future trials [86] and is consistent with our previously published pilot studies [29,35,39,61]. The frequency and proportions of the feasibility benchmarks will be calculated separately for AB-F and HEP. Additional quantitative analysis will focus on descriptive statistics for each measure, within-group pre-post comparisons using paired t tests, Cohen d effect sizes to explore signals of improvement in AB-F, and exploratory correlations between outcomes (physical, cognitive, and emotional function) and program targets (eg, mindfulness and coping). Qualitative analysis will be primarily deductive [88] using the framework method based on our prior work [13], allowing for some inductive flexibility to explore the unexpected needs and preferences of participants [89].

CP and CD are frequently comorbid among older adults [4]. CP symptoms exacerbate CD and vice versa [5], leading to a disability spiral of worsened physical, cognitive, and emotional functioning [11,12]. The AB-F program addresses an important clinical gap, as no effective treatments are currently available for this population. The 2 AB-F development studies conducted thus far provide preliminary evidence that combining mind-body and activity skills with Fitbit is feasible; acceptable [13,29]; and shows promise for improving physical, cognitive, and emotional outcomes among older adults with CP and CD. This protocol provides a blueprint for an entirely virtual, single-blind feasibility RCT of AB-F versus a time- and dose-matched educational control (HEP) in older adults with CP and CD. Importantly, our technological adaptations are consistent with older patients’ evolving preferences for live video delivery and bypass barriers to nonpharmacological treatments identified in the literature [30] and older adults in our prior studies (eg, transportation) [13,29] as well as the recent threat of COVID-19. To our knowledge, this is the first trial to integrate a live video, a smartphone, and wearable technologies to enhance treatment development for older adults with CP and CD.

This mixed methods study will help us maximize the feasibility, credibility, acceptability, and adherence of the AB-F and HEP programs. Quantitative and qualitative data will be integrated to corroborate the feasibility of AB-F, contextualize the findings at multiple levels (group and individual participant), explore whether technological adaptations helped or hindered participation, and understand changes in the outcomes [90]. The results will inform a subsequent virtual efficacy RCT (NIA stage II; Figure 1). In the future efficacy RCT, we will test our hypothesis that AB-F is superior to HEP in improving physical, cognitive, and emotional functioning in older adults with CP and CD. In the fully powered trial, we will test the mechanistic hypotheses that AB-F indirectly improves these outcomes through additional targets, such as increasing mindfulness, self-compassion, and pain resilience, while decreasing pain catastrophizing and kinesiophobia.

Although this trial is ongoing, preliminary findings are promising for the feasibility of both programs and our study methodology conducted virtually. Older adults with CP and CD appear to be able to engage in remote data collection and live video group participation, including the use of multiple technology platforms (ActiGraph, Fitbit, and Zoom). This suggests that our protocols for recruitment and teaching technology as well as our overall methodology show promise. Direct participant feedback will help us further address the technological challenges that our target population might experience. However, qualitative studies [91], including our prior work in this population [13,29], suggest that older adults are motivated to learn the live video [32] and wearable [92,93] technology used in this study. Our exit focus groups and lessons learned from study staff will help us develop further strategies to make the multiple technologies used during the program more accessible to older adults with CP and CD.

Despite the novelty of our entirely virtual mind-body and activity program, there are several limitations. First, our recruitment was restricted by the racial and ethnic distribution of patients at our pain clinic and memory clinic. Our future efficacy RCT will need to focus specifically on recruiting a sample that is representative of the US racial and ethnic composition by ensuring that we approach all racial and ethnic minorities or engage in targeted recruitment at the national level. Second, we did not formally assess the level of cognitive impairment at screening. Although no participants had a baseline MoCA score indicative of dementia (<18) [94], we plan to administer the Portable Mental Health Questionnaire [95] in future trials to screen for severe CD that would interfere with the programs or study procedures.

Consistent with the early stages of the NIA model [23], optimizing our remote delivery procedures before conducting the virtual efficacy RCT is critical for ensuring feasibility, aligning the AB-F with our target population, and detecting meaningful changes [87]. If successful, the AB-F will be the first completely virtual intervention for older adults with CP and CD and can be routinely incorporated into telehealth practices. The need for nonpharmacological interventions that are amenable to remote delivery, such as mind-body and activity programs, has grown in response to COVID-19. We hope that in-depth descriptions of live video adaptations of study procedures will assist researchers conducting virtual clinical trials of similar programs for in-need populations.