Dataset Information

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

ABSTRACT: 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.

SUBMITTER: Sakakibara BM

PROVIDER: S-EPMC6330197 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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

Sakakibara Brodie M BM Chakrabarti Santabhanu S Krahn Andrew A Mackay Martha H MH Sedlak Tara T Singer Joel J Whitehurst David Gt DG Lear Scott A SA

JMIR research protocols 20190111 1

<h4>Background</h4>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.<h4>Objective</h4>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-mana ...[more]

PMID: 30635261

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Project description:BackgroundBlack men are more likely to be diagnosed with type 2 diabetes (T2D) compared to non-Hispanic White men, and this disparity increases among men over the age of 55. A growing body of literature demonstrates the critical role of gender in the management of health behaviors such as T2D and shows that male gender norms can conflict with healthy behaviors. These studies suggest that tailoring diabetes self-management interventions to address the needs of Black men may be critical to helping them to achieve optimal health outcomes. Further, our own research on Blacks with T2D found gender disparities in participation in diabetes interventions, with males participating at significantly lower rates than females. Peer leaders are trained lay individuals who are used to provide ongoing diabetes self-management support to people with diabetes, particularly in minority communities. However, despite studies showing that diabetes management interventions using peer leaders have been successful, the majority of peer leaders as well as the participants in those studies are women. The limited studies to date suggest that Black men with T2D prefer peer-led, male-to-male T2D programs, however, this research consists primarily of nonrandomized, small sample feasibility studies calling for additional studies to establish the efficacy of these approaches. The proposed study will develop and preliminarily validate the effectiveness of an adapted peer leader diabetes self-management support (PLDSMS) intervention designed to improve diabetes-related lifestyle and self-management behaviors in Black men (over 55) with T2D.MethodWe propose to tailor an existing intervention by 1) our using male peers and 2) modifying the peer leader training content to focus on material appropriate for men. The proposed study includes a developmental phase (development of the intervention with expert feedback, followed by feasibility testing with Black men) and a validation phase [randomized clinical trial (RCT)].DiscussionIf successful, this study will lead to the development and dissemination of an intervention that will address the unique needs of Black men with T2D, helping them to achieve optimal diabetes self-management and health outcomes.Trial registrationRegistered at ClinicalTrials.gov with an ID NCT04760444 on February 17, 2021.

Project description:BackgroundPain self-management is an effective, evidence-based treatment for chronic pain. Peer support, in which patients serve as coaches for other patients, has been effective in other chronic conditions and is a potentially promising approach to implementing pain self-management programs using fewer clinical resources.ObjectiveTo test a peer coach-delivered pain self-management program for chronic pain.DesignRandomized controlled trial.ParticipantsVeterans with chronic musculoskeletal pain.InterventionIntervention patients were assigned a trained peer coach for 6 months. Coaches, who were volunteers, were asked to contact their assigned patients, either by phone or in person, twice per month. Coaches and patients were given an intervention manual to guide sessions. The control group was offered a 2-hour pain self-management class.Main measuresThe primary outcome was total pain, assessed by the Brief Pain Inventory (BPI). Secondary outcomes were anxiety, depression, pain catastrophizing, self-efficacy, social support, patient activation, health-related quality of life, and healthcare utilization. Outcomes were measured at baseline, 6 months, and 9 months.Key resultsTwo hundred fifteen patients enrolled (120 intervention, 95 control). Adherence to intervention protocol was low, with only 13% of patients reporting having at least the recommended 12 peer coach meetings over the 6-month intervention. BPI total decreased from baseline to 6 months and baseline to 9 months in both groups. At 9 months, this change was statistically significant (intervention, - 0.40, p = 0.018; control, - 0.47, p = 0.006). There was not a statistically significant difference between groups on BPI at either time point. No secondary outcomes improved significantly in either group after adjusting for multiple comparisons.ConclusionsPatients randomized to peer support did not differ from control patients on primary and secondary outcomes. Other peer support models that do not rely on volunteers might be more effective.Trial registrationClinicalTrials.gov Identifier: NCT02380690.

Project description:BACKGROUND:Patients with diabetes and poorly controlled hypertension are at increased risk for adverse renal and cardiovascular outcomes. Identifying these patients early and addressing modifiable risk factors is central to delaying renal complications such as diabetic kidney disease. Mobile health (mHealth), a relatively inexpensive and easily scalable technology, can facilitate patient-centered care and promote engagement in self-management, particularly for patients of lower socioeconomic status. Thus, mHealth may be a cost-effective way to deliver self-management education and support. OBJECTIVE:This feasibility study aimed to build a population management program by identifying patients with diabetes and poorly controlled hypertension who were at risk for adverse renal outcomes and evaluate a multifactorial intervention to address medication self-management. We recruited patients from a federally qualified health center (FQHC) in an underserved, diverse county in the southeastern United States. METHODS:Patients were identified via electronic health record. Inclusion criteria were age between 18 and 75 years, diagnosis of type 2 diabetes, poorly controlled hypertension over the last 12 months (mean clinic systolic blood pressure [SBP] ?140 mm Hg and/or diastolic blood pressure [DBP] ?90 mm Hg), access to a mobile phone, and ability to receive text messages and emails. The intervention consisted of monthly telephone calls for 6 months by a case manager and weekly, one-way informational text messages. Engagement was defined as the number of phone calls completed during the intervention; individuals who completed 4 or more calls were considered engaged. The primary outcome was change in SBP at the conclusion of the intervention. RESULTS:Of the 141 patients enrolled, 84.0% (118/141) of patients completed 1 or more phone calls and had follow-up SBP measurements for analysis. These patients were on average 56.9 years of age, predominately female (73/118, 61.9%), and nonwhite by self-report (103/118, 87.3%). The proportion of participants with poor baseline SBP control (50/118, 42.4%) did not change significantly at study completion (53/118, 44.9%) (P=.64). Participants who completed 4 or more phone calls (98/118, 83.1%) did not experience a statistically significant decrease in SBP when compared to those who completed fewer calls. CONCLUSION:We did not reduce uncontrolled hypertension even among the more highly engaged. However, 83% of a predominately minority and low-income population completed at least 67% of the multimodal mHealth intervention. Findings suggest that combining an automated electronic health record system to identify at-risk patients with a tailored mHealth protocol can provide education to this population. While this intervention was insufficient to effect behavioral change resulting in better hypertension control, it does suggest that this FQHC population will engage in low-cost population health applications with a potentially promising impact. TRIAL REGISTRATION:ClinicalTrials.gov NCT02418091; https://clinicaltrials.gov/ct2/show/NCT02418091 (Archived by WebCite at http://www.webcitation.org/76RBvacVU).

Dataset Information

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

Publications

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

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