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Cardiovascular disease (CVD) is a leading cause of hospitalization and death around the world. The prevalence of CVD is increasing and, therefore, development and investigation of effective programs to help people better self-manage their CVD and prevent secondary complications are needed.
In this paper, we report on a protocol to evaluate Healing Circles—an evidence-based and patient-informed peer support mobile health program designed to facilitate self-management and support patients in their recovery from and management of CVD. We hypothesize that individuals with CVD who use Healing Circles will experience greater improvements to their self-management ability than individuals receiving usual care.
In this single-blinded (assessor) randomized controlled trial, 250 community-living individuals with CVD will be randomized on a 1:1 basis to either Healing Circles or Usual Care. The primary outcome of self-management will be measured using the Health Education Impact Questionnaire version 3.0. Secondary outcomes include self-efficacy with chronic disease management, health-related quality of life, health resource use and costs, and electronic health literacy. Measurements will be taken at the baseline and every 6 months for 24 months.
The study started recruitment in September 2017. Individuals are currently being recruited for participation, and existing participants are currently on follow-up. Measurements will be taken every 6 months until the study end, which is anticipated in December 2019.
Healing Circles is a novel program aimed toward improving self-management through peer support. Given our real-world study design, our findings will be readily translatable into practice. If the results support our hypothesis, it will indicate that Healing Circles is an effective intervention for improving self-management and reducing health care use.
ClinicalTrials.gov NCT03159325; https://clinicaltrials.gov/ct2/show/NCT03159325 (Archived by WebCite at http://www.webcitation.org/74DvxVKUd)
DERR1-10.2196/12322
Cardiovascular disease (CVD) is a leading cause of hospitalization and death around the world [
Patient self-management, defined as an individual’s ability to manage the symptoms, treatment, physical and psychosocial consequences, and lifestyle changes inherent in living with one or more chronic conditions [
Despite benefits from self-management programs, questions remain as to how these programs can be implemented. Much discussion has centered on integrating self-management within the health care systems in Canada and the United States [
In this study, we report the protocol of a real-world randomized controlled trial to evaluate Healing Circles—a mobile health (mHealth) self-management and social support program designed to bring peers with CVD together to learn from and support each other in the recovery and daily management of their disease. The primary hypothesis of this study is that individuals with CVD who participate in Healing Circles will experience improvements in their self-management ability, which are significantly greater than individuals receiving usual care. We are also investigating the effects of Healing Circles on the health-related quality of life, self-efficacy with chronic disease management, electronic health (eHealth) literacy, and health care resource use as part of our economic evaluation.
This multisite study uses a randomized, controlled, parallel-group, single-blinded (assessor) study design, which has been guided by our Healthcare Innovation Community advisory group of researchers, clinicians, patients, and decision makers. This study has been registered on ClinicalTrials.gov (#NCT03159325). The reporting of this protocol follows the Standard Protocol Items: Recommendations for Intervention Trials [
Volunteers from British Columbia, Canada, will be recruited from cardiac outpatient clinics and community-based CVD support groups. Individuals will be included for study if they (1) have a CVD (ischemic heart disease, atrial fibrillation, heart failure, or patients with implantable cardioverter-defibrillator; together these are nearly 80% of patients with CVD); (2) are aged ≥19 years; (3) own or have regular access to either a smartphone (Android or iOS operating system), tablet, or laptop or desktop computer; and (4) can speak, write, and comprehend English. Individuals will be excluded if they (1) have cognitive or physical impairments that may interfere with effective interaction with the Healing Circles program; (2) have a known planned surgical intervention; (3) have another household member in the study; or (4) are unable to provide informed consent.
Data from our single-group, pre-post pilot study that examined the proof-of-concept of the Healing Circles program [
Overview of trial procedures.
After the baseline assessment, participants will be stratified by sex and recruitment site, and randomized using Web-based, computer-generated, random block sizes of 4 and 6 in a 1:1 manner to either the Usual Care or the Healing Circles group. A member of the research team who is not involved with recruitment, assessments, or study intervention will perform the randomization procedures.
Participants randomized to the usual care group will receive a list of internet-based resources appropriate for their specific CVD. For many participants, usual care will comprise the care provided by their family physician. By virtue of our recruitment, some participants will be attending cardiac outpatient clinics and may receive some self-management education as a result. However, participants are unlikely to have access to formalized peer support programs or regular access to expert input or advice. There will be no contact between the study personnel and Usual Care participants for the study duration or any attempt to influence any aspect of patient care.
In addition to receiving care as usual, participants randomized to the intervention group will receive access to and instruction on how to use (ie, provision of an on-boarding document) the Healing Circles program. Healing Circles is a novel, evidence-based, and patient-informed self-management platform designed to support patients with CVD. It uses a private, secure social network that helps connect participants and provides functions to assist participants in self-management through evidence-based principles of behavioral change (eg, social support [
Healing Circles has 3 following layers: (1) the participant; (2) the participant’s circle, and (3) the broader Healing Circles community. The participant’s circle is the private group that consists of other Healing Circle users that a participant chooses to support him or her (ie, an online support group). These private circles are used for private group or one-on-one chat and communication, peer support, challenges, and sharing. The broader community comprises all Healing Circles users, where participants can see public posts from others not in their circle.
Participants access Healing Circles by downloading or installing, at no cost, the platform onto their personal device (smartphone or tablet). Upon initiating Healing Circles, participants are asked to enter optional information about themselves such as gender, age, cardiac condition, region of residence, types of treatments, and personal interests and hobbies. This information allows the platform to customize and personalize the user experience, from suggesting peers with whom to connect with and add to their support circle, to personalizing content and customizing management tracking tools. However, entering this information is optional and is kept private and secure in accordance with Canadian and American data privacy laws (ie, Personal Information Protection and Electronic Documents Act in Canada and the Health Insurance Portability and Accountability Act in the United States). The participants’ next step is to form their own circle of 8-10 “friends”. Social support is strongest when coming from peers who have similar characteristics and who possess knowledge that is pragmatic and derived from similar lived experiences [
Participants also have access to evidence-based educational materials on CVD as well as several functions such as
The primary outcome is the difference in the change in the social integration and support subscale of the HeiQ Version 3 [
We selected the 5-item social integration and support subscale as our primary outcome because the items align closely with the Healing Circles intervention, and results from our pilot study suggested that this subscale is most responsive to changes as a result of the Healing Circles program [
Secondary outcomes include the 7 other subscales within the HeiQ as well as several other variables as follows.
Generic preference-based measures of
Finally,
Descriptive statistics will be used to characterize the sample. For the analysis of the primary outcome, the social integration, and support subscale of the HeiQ, we will evaluate the difference in change scores between groups using a mixed-effects model that takes into account the repeated measures of the outcome. The model will incorporate the strata of sex and method of recruitment, as well as control for sociodemographic covariates such as age and sex.
With the exception of the data collected for the economic analysis, all other continuous outcomes (our secondary outcomes), including the other 7 subscales of the HeiQ, will also be assessed using a mixed-effects model. In addition, we will investigate whether there are associations of the primary and secondary outcomes with sex, urban or rural residence, disease status, and eHealth literacy. Nonnormally distributed continuous variables will be transformed prior to analyses. All analyses will be tested using an alpha of.05.
The primary framework for the economic analysis will be a cost-consequence analysis, where resource use, costs, and outcomes of the 2 treatment groups are listed separately in a disaggregated format (eg, hospital costs, out-of-pocket expenses, self-management outcomes, health-related quality of life, and capability well-being). The time horizon for the cost-consequence analysis will complement the study’s design for the follow-up to maximize the use of available data (ie, 0-6, 0-12, 0-18, and 0-24 months).
We will also perform a cost-utility analysis from the perspective of the publicly funded health care payer, in line with recommendations from the Canadian Agency for Drugs and Technologies in Health [
Baseline will consist of the collection of our primary and secondary outcomes that require pre and post measurements, as well as social demographic data, medical history, and eHealth literacy using the eHealth Literacy Scale (eHEALS) [
Every 6 months between randomization and the study’s end (anticipated in December 2019), participants will undergo an assessment of outcomes only. Those recruited at the end and beginning of recruitment will experience follow-up periods ranging from 6 to 24 months (2 years), respectively. We expect an average of 18 months of follow-up. In addition, we anticipate that the main effects on self-management will occur early after randomization; however, extended follow-up will allow us to investigate the sustainability of any observed effect, Healing Circles’ use over time, and health care use for an extended period. Participants may complete data collection either in-person with a blinded assessor, self-report through mailed responses, or on the Web. The study started recruitment in September 2017. Individuals are still currently being recruited for participation, and existing participants are currently on follow-up.
This study is funded by the Canadian Institutes of Health Research eHealth Innovations Partnership Program and the Michael Smith Foundation for Health Research. Ethical approval has been obtained, all study staff have been hired and trained, and recruitment is currently under way.
Healing Circles is a novel program aimed at improving self-management through peer support, as well as recovery from and management of CVD. Given our real-world study design and the participatory aspects of engaging end users, our findings could be readily translated into practice. If the results support our hypotheses, it will indicate that Healing Circles is an effective intervention for improving self-management and reducing health care use. If so, this robust assessment of the implementation and use of Healing Circles could be used to inform future design of the program and inform plans for scale-up.
Peer-reviewer report from the Canadian Institutes of Health Research.
cardiovascular disease
electronic health
EuroQoL-5 dimension 5-level version
Health Education Impact Questionnaire
ICEpop CAPability measure for Adults
mobile health
quality-adjusted life year
This study was supported by the Canadian Institutes of Health Research Postdoctoral Fellowship (BMS); Michael Smith Foundation for Health Research Postdoctoral Fellowship (BMS) and Scholar Award (MHM); and Pfizer/Heart and Stroke Foundation Chair in Cardiovascular Prevention Research at St. Paul’s Hospital (SAL).
SAL reports being the Chief Scientific Officer for Curatio, the mHealth company that developed the Healing Circles program.