Peer Support and Remote Patient Monitoring for Black Adults With Type 2 Diabetes
- Conditions
- Type 2 Diabetes
- Registration Number
- NCT07181304
- Lead Sponsor
- University of Alabama at Birmingham
- Brief Summary
This study will include a type 1 hybrid effectiveness implementation study to evaluate the effectiveness of the PROMOTE (peer support plus remote patient monitoring) program among Black adults with uncontrolled type 2 diabetes recruited from local primary care practices in Jefferson County, Alabama. Additionally, we will conduct a mixed methods evaluation to characterize the contextual factors relevant to implementation of PROMOTE using Practical Robust Implementation Science Model (PRISM).
- Detailed Description
In the proposed study, we will conduct a type 1 hybrid effectiveness-implementation randomized controlled trial (RCT) of peer support plus remote patient monitoring as well as a mixed methods evaluation of contextual factors relevant to program delivery and implementation. We will recruit Black adults with uncontrolled type 2 diabetes (A1C \>8%) from primary care practices in Jefferson County, Alabama to participate in this RCT.
Specific Aim 1: To evaluate the effectiveness of the PROMOTE (peer support plus remote patient monitoring) program among Black adults with uncontrolled type 2 diabetes in Jefferson County, Alabama. Hypothesis: The PROMOTE program will be effective, leading to clinically meaningful improvements in glycemic control.
We will test the PROMOTE program in a type 1 hybrid effectiveness-implementation RCT among Black adults with uncontrolled type 2 diabetes (A1C \>8%). We will be working with primary care practices in Jefferson County, Alabama through a consortium of community-based primary care providers who aim to improve healthcare delivery and outcomes by integrating research into their daily practice of medicine. Participants will be randomized 1:1 to intervention (PROMOTE) or control condition. Both study arms will receive diabetes self-management education and support (DSMES) delivered virtually. Participants randomized to the PROMOTE program will receive core components of peer support, remote patient monitoring of blood glucose, and integration with clinical care. Peer support will be delivered by trained ConnectionHealth CHWs with an initial in-person visit, followed by phone visits weekly for 3 months, then monthly for 3 months. ConnectionHealth is a 501c3 nonprofit organization that was founded in December 2014 in Birmingham, Alabama dedicated to training and deploying community health workers (CHWs) to address the needs of Alabama's most vulnerable citizens. Currently, ConnectionHealth serves citizens in Jefferson County, Shelby County, and the Black Belt Region of rural Alabama, providing community-based support with the goal of assisting clients to achieve healthier lives. We will partner with UAB eMedicine to deliver remote patient monitoring program. UAB eMedicine has an active remote patient monitoring program that is currently monitoring over 900 patients. All glucose values are transmitted via cellular enabled devices; the patients do not need access to their own internet plan or to their own smart device, which ensures that there are no disparities related to the technology. Furthermore, test strips are provided to patients on a regular basis by the program based on the number of readings performed, which eliminates a barrier of cost. Participants will be asked to check blood glucose with remote patient monitoring daily for 6 months, frequency tailored to their medication regimen. Monthly reports of peer support and remote patient monitoring activities will be provided to primary care providers. Clinical and patient-reported outcomes will include change from baseline to 6 months for the following: A1C (primary), as well as secondary outcomes of blood pressure, low density lipoprotein levels, body mass index, diabetes self-management, and diabetes distress. Clinical outcome will be extracted from the electronic health record and patient reported outcomes will be obtained via patient survey using validated measures. The main analysis will used linear mixed effects models to model change in each outcome (e.g. A1C) by study group (intervention vs. control arms), adjusted for the baseline value, accounting for any meaningful clustering using random intercepts. The hypotheses of an intervention effect will be tested by the significance of the coefficient for study group at the p\<0.05 level.
Specific Aim 2: To characterize the contextual factors relevant to implementation of PROMOTE using Practical Robust Implementation Science Model (PRISM) through mixed methods evaluation.
PRISM is a context-oriented framework that aligns well with this study because it is intended to be used across program phases from pre-implementation, implementation, evaluation, and sustainment phases with a focus on the contextual domains closely tied to the outcomes of the RE-AIM framework (Reach Effectiveness Adoption Implementation and Maintenance).35 With our primary care practices, we will use purposeful recruitment to identify provider participants with a goal of 2-4 key informant provider participants per site with the following roles represented including physicians and advanced practice providers, nurses, care coordinators, and administrative staff. We will use parallel convergent mixed methods utilizing PRISM to assess perspectives and characteristics at the organizational and patient levels, as well as implementation and sustainability infrastructure and external environment, to determine key contextual factors that serve as implementation determinants.23 These results will be applied to determine future implementation strategies.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Age 19 years or older
- Black race (self-reported)
- Diagnosis of type 2 diabetes
- Uncontrolled A1C >8%
- Receipt of care at one of the study sites
- Speaks and reads in English
- Limited English proficiency
- Currently pregnancy
- Non-community dwelling.
- Speaks and reads in English
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Hemoglobin A1c (A1C) Baseline, 6-months Change in A1C value at 6-months compared to baseline. Lab values will be extracted from electronic health record. Per the American Diabetes Association (ADA) Standards of Care, A1C is recommended to be checked quarterly for patients with type 2 diabetes, whose A1C is not at target level (i.e. the eligibility criteria for this study sample).
- Secondary Outcome Measures
Name Time Method Change in blood pressure Baseline, 6-months Biometric data will be extracted from electronic health record by study personnel. Blood pressure is recommended to be checked at each followup visit for patients with type 2 diabetes; recommended follow-up visit frequency of every 3 months for patients whose A1C is not at the target level.
Change in Low Density Lipoprotein (LDL) Baseline, 6-months Laboratory data will be extracted from electronic health record by study personnel. Per the American Diabetes Association (ADA) Standards of Care, LDL is recommended to be checked annually for patients with type 2 diabetes
Change in Body Mass Index (BMI) Baseline, 6-months Biometric data will be extracted from electronic health record by study personnel. BMI is recommended to be measured at each followup visit for patients with type 2 diabetes; recommended follow-up visit frequency of every 3 months for patients whose A1C is not at the target level.