Bridging Income Generation With Group Integrated Care

Summary

Specific Aims: Bridging Income Generation with GrouP Integrated Care (BIGPIC) Over 80% of cardiovascular disease (CVD) deaths occur in low- and middle-income countries (LMICs). Diabetes, a major risk factor for CVD, is also responsible for substantial morbidity and mortality in LMICs. Elevated blood pressure (BP) increases CVD risk among individuals with diabetes and pre-diabetes; BP control is therefore a powerful way to reduce CVD risk. Cost-effective, culturally appropriate, and context-specific approaches are critical. Two promising strategies to improve health outcomes are group medical visits and microfinance. Both can increase quality of care, clinician-patient trust, self-efficacy, health savings, self-confidence, group cohesion, and social support. While these strategies have been successful in other contexts, their impact on CVD risk reduction among diabetics and pre-diabetics in low-resource settings is not known.

In partnership with the Government of Kenya, the Academic Model Providing Access to Healthcare (AMPATH) Partnership has expanded its clinical scope of work to include diabetes and hypertension. AMPATH has piloted group care and microfinance initiatives among patients with chronic diseases with promising early results. Both strategies are feasible, as is integration of group medical visits into microfinance groups. However, the effectiveness of these strategies individually, and in combination, on improving CVD risk is not known.

Thus, the objective of this proposal is to utilize a transdisciplinary implementation research approach to address the challenge of reducing CVD risk in low-resource settings. The central hypothesis is: group medical visits integrated into microfinance groups will be effective and cost-effective in reducing CVD risk among individuals with diabetes and at increased risk for diabetes in western Kenya, and that the key modifiable CVD risk factor to be addressed is BP. The research team hypothesize that group medical visits and microfinance may each reduce CVD risk, but the integration of group medical visits and microfinance will yield the largest gains. Also further hypothesize is that changes in social network characteristics may mediate the impact of interventions on the primary outcome, and that baseline social network characteristics may moderate the impact of interventions. To test these hypotheses and achieve the overall objectives, the following specific aims will be pursued:

Aim 1: Identify the contextual factors, facilitators, and barriers that may impact integration of group medical visits and microfinance for CVD risk reduction, using a combination of qualitative research methods: 1) baraza (traditional community gathering) form of inquiry; and 2) focus group discussions among individuals with diabetes or at increased risk for diabetes, microfinance group members, and rural health workers.

Subsidiary Aim 1.1: Use identified facilitators and barriers to develop a contextually and culturally appropriate integrated group medical visit-microfinance model to reduce CVD risk among individuals with diabetes or at increased risk of diabetes. This model's acceptability and feasibility will be assessed by conducting focus group discussions with patients, microfinance group members, and health workers.

Aim 2: Evaluate the effectiveness of group medical visits and microfinance groups for CVD risk reduction among individuals with diabetes or at increased risk for diabetes, by conducting a four-arm cluster randomized trial comparing: 1) usual clinical care; 2) usual clinical care plus microfinance groups only; 3) group medical visits only (no microfinance); and 4) group medical visits integrated into microfinance groups. The primary outcome measure will be one-year change in systolic blood pressure (SBP), and a key secondary outcome will be change in QRISK2 CVD risk score, which has been validated for Black Africans.

Subsidiary Aim 2.1: Conduct mediation analysis to evaluate the influence of changes in social network characteristics on intermediate factors and intervention outcomes and moderation analysis to evaluate the influence of baseline social network characteristics on effectiveness of interventions.

Aim 3: Evaluate the incremental cost-effectiveness of each intervention arm of the trial, in terms of costs per unit decrease in SBP, per percent change in CVD risk score, and per disability-adjusted life year saved.

This research project will add to the existing knowledge base on innovative, scalable, and sustainable strategies for reducing CVD risk in diabetes and other chronic diseases in LMICs and other low-resource settings. If proven to be effective, the investigators are poised to expand the approach beyond the trial, thus ensuring that this research will have a significant and positive health impact on a larger population.

Conditions

• Cardiovascular Disease
• Diabetes

Interventions

OTHER

Usual Clinical Care

Non-hypertensive diabetic individuals will not be pharmacologically treated for BP reduction; those with BP 120-139/80-89 will be advised on lifestyle changes to reduce BP as recommended by the 2013 Standards of Medical Care in Diabetes. Care will be provided to each individual at the rural health facility by a rural clinician mentored by the CDM Program, including regular monthly consultation, vital signs, physical examination, and prescriptions. CHWs will assist with linkage and retention of patients to the care program, and provide health education. The 12-month follow-up BP will be measured in the rural health facility, in order to mimic real-world practice. If the patient does not present to the rural health facility for the 12-month visit, the local CHW will trace the patient at home and will check the 12-month BP at that time, again consistent with real-world conditions.

OTHER

Group Medical Visits

The CHW will facilitate a group discussion about a self-care or health education topic chosen by the group while the rural clinician reviews the BP, sugar, and adherence data to determine a clinical recommendation as per the CDM clinical algorithm. which is communicated to each individual patient privately by the rural clinician in a five-minute "breakout time". The rural clinician will not change the regimen for non adherence but instead will use the breakout time to assess barriers to adherence and try to help the patient identify solutions to those barriers.The breakout time can also be used to perform a physical examination or other assessments as clinically required. After all patients have had individual consultations with the rural clinician, the entire group re-convenes for a closing session, which consists of a question-and-answer period and determination of the next session's self-care or health education topic.

OTHER

Microfinance Groups

The rural clinician and the CHW will organize a meeting with AMPATH's Safety Net Program representatives, who will introduce the concept of microfinance groups, the potential benefits, and encourage the formation of new groups to meet monthly. The microfinance groups need to incorporate an element of self-selection and self-formation, so that individuals have the freedom to choose with whom they will create a group. The groups are therefore formed voluntarily, and usually along geographical boundaries, which facilitates participation, retention, and meeting logistics.

Sponsors & Collaborators

• Moi University College of Health Sciences

  collaborator UNKNOWN

• Brown University

  collaborator OTHER

• Duke University

  collaborator OTHER

• Purdue University

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• NYU Langone Health

  lead OTHER

Principal Investigators

• Rajesh Vedanthan, MD, MPH · NYU Langone Health

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-02-06

Primary Completion

2019-12-29

Completion

2019-12-29

Countries

• Kenya

Study Locations