Delivery of Peer Support Through a Self-Management mHealth Intervention (Healing Circles) in Patients With Cardiovascular Disease: Protocol for a Randomized Controlled Trial

Background 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. Objective 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. Methods 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. Results 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. Conclusions 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. Trial Registration ClinicalTrials.gov NCT03159325; https://clinicaltrials.gov/ct2/show/NCT03159325 (Archived by WebCite at http://www.webcitation.org/74DvxVKUd) International Registered Report Identifier (IRRID) DERR1-10.2196/12322


Brief synopsis
This project proposes to test the effectiveness of the use of the Healing Circles, peer support and social networking platform, to improve self-management skills (e.g., adherence to medication and healthy life style) for older patients with CVD who tend to be isolated, for cardiovascular disease (ischemic heart disease, arrhythmias and HF) QOL, and health service use. They will test using 250 participants who are randomly assigned to the intervention group and usual care. 8-10 matched participants form a group and receive information/education from the Heart and Stroke Foundation of Canada (experts). Technology was developed by Curio (Vancouver based) and delivers a low-cost and highly accessible solution through PC, tables, and smart phones, thereby readily scalable. Nurses in clinics will introduce patients to the system. Due to minimal involvement with a current health care system, the scalability has great potential. For the RCT, the intervention is 6 months and will follow up to 2.5 years. Comments This is an interesting and unique proposal that does not involve clinical settings to improve patients' health behaviors through peer support, although can be controversial. This has an advantage for patients due to no cost and may disseminate fast and can engage any stage of illness conditions. Include objective measurements for health behaviors are lacking.

Planned Intervention: Strength
This proposal deals with health behavior promotion necessary for chronic disease management outside the clinical network. This operation is free for enrollees and they can invite a person to be in a group depending on their profile and can be in more than one group. Since this acts like social media, older people may really use it. Expert support, reminders, health tracking and challenges, as well as technical support are helpful. The scalability is good due to very minimal involvement in the current health care system, and involvement of the Heart and Stroke Foundation (HSF) as well as the Canadian Cardiovascular Society. This is a great way for the HSF to disseminate knowledge.

Weakness
Assessment/Évaluation: Weakness This is not a weakness but on page 8, in Inclusion criteria, iPhone is omitted but this was used for the pilot study, so it should be included. How medication adherence will be measured? There is no objective measure for health behaviors. Is this an intent-to-treat analysis? Because of non-involvement of clinical settings and specific devices, and rather simple technology, which was tested and apparently further improvement is not needed, the study can be done in 3 years. Who will train/teach technology to participants? A Study coordinator? How the involvement of study coordinator will affect scalability of this project?

Planned Intervention
This intervention is very relevant to the senior population with cardiovascular disease a large group within the Canadian healthcare system. The technology has been piloted with success and will reach TRL level within first year of project. Providing a web-based platform that involves social support is innovative and cost effective. Scalability on proof of concept is very feasible. The stories' of patients with CVD strengthen the patient-oriented approach. With the strong support of the HSF, end-user co-development will more likely be effective. The implementation plan is very dependent on CVD patient comfort with the social networking concept and willingness to form their primary circle of support which could be a drawback. Clinician support will be dependent on the time it takes to monitor their patients using social media.

eHealth Innovation Evaluation
The sample si e is quite small but appears to reflect the local population who currently have access to the platform technology. The outcomes facilitated self-management with peer support, are ones that are advocated for by other patient groups, in particular seniors, who want to maintain control of their own health. reater patient engagement in the analysis will lead to a wider audience for T spread. The current environment determined by the level of acceptance of mobile technologies in our society is very good for this innovation. Team: The partnership between the health-care innovation community and the health technology partners seems quite strong given that they have engaged in previous partnerships. The support of the Heart and Stroke Foundation also speaks to a strong team ready to co-develop and integrate this eHealth solution. The scientific team includes leaders from academia, clinical areas, and the HSF which has the capacity to conduct the proposed activities and undertake the evaluation. Cardiovascular disease is a leading cause of death and disability in Canada costing 22.2 billion annually. Patient self-management is key in better patient outcomes and reducing hospital visits. This project plans to build the popularity of social networks and create mini-health circles and groups to facilitate support from other patients.
The population is relevant and has appropriate challenges the gap is in the effective delivery of self-managed support. Effective delivery can reduce depression, provide comfort, restore confidence, improve functional status and offer practical solutions resulting reduced mortality and subsequent hospital visits. The technology appears to be a TRL and can easily move higher based on its current state. Based on provided testimonials, previous testing and partnerships and overall plan it should improve outcomes for the targeted population with respect to self-management. The solution itself is cloud based and easily scalable. iven its social nature it would most likely benefit from scaling and having more users involved. Once it is proven and environmental and use-case is sorted out, scaling is relatively easy. The environment is hospital base and under a health research team.
The partners for this project have worked together previously. They have developed the preliminary and early testing portions of this project already and have done some testing and implementation to get it to where it is as right now. Based on this it is believed there is a high probability that it will succeed. The technology platform is itself ready, it would be relatively minimal work to scale up the solution and get it deployed based on the previous work already completed and should have ample capacity to deliver the solution. All parties appear to have high quality members with relevant experience necessary and the ability to make the decisions required and the technology partner has a strong advisory group. The health research team and hospital setting are suitable, allow for direct access to the necessary people and the team has worked together on this project before with success. The people involved are active and accessible and the location and infrastructure are available and have been developed and setup previously.
The technology company is small and young however the major financial requirements have already been fulfilled and the additional requirements for the purposes of this application are minimal and can satisfied. The technology platform benefit is one that it facilitates and allows patients to support each other through Delivery of self-management through a peer-support telehealth intervention in patients with cardiovascular disease: The Healing Circles Project recovery process thus improving the patient outcomes and possibly lowering the amount of visits and interactions with medical professionals in a hospital environment. The commerciali ation potential of the technology is strong as it is already selling and being implemented in some forms. This application would allow the technology to be finali ed for this particular demographic and be scaled up. The infrastructure currently exists for the platform which is already operational on various levels so the required commerciali ation is within the capacity of the company. The previous work demonstrates the customer market and as a niche it should be highly adoptable. The main barrier will be the business model and backing up the sales pitch with hard data proving this works and will save money vs being a perk for a potential client. The budget itself appears appropriate, not excessive and meets the requirements and this project should be funded.