NCT02501746: BIGPIC

Bridging Income Generation With Group Integrated Care

Completed NA Last updated 17 June 2020

What this trial tests

NA trial testing Usual Clinical Care in Cardiovascular Disease in 2,890 participants. Completed in 29 December 2019.

Timeline

6 February 2017

Primary endpoint
29 December 2019

29 December 2019

Quick facts

Lead sponsor	NYU Langone Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	2,890
Start date	6 February 2017
Primary completion	29 December 2019
Estimated completion	29 December 2019
Sites	1 location across Kenya

Drugs / interventions tested

• Usual Clinical Care
• Group Medical Visits
• Microfinance Groups

Conditions studied

• Cardiovascular Disease — all drugs for Cardiovascular Disease →
• Diabetes — all drugs for Diabetes →

Sponsor

NYU Langone Health — full company profile →

Who can join

35 and older, any sex, with Cardiovascular Disease or Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Group Medical Visit and Microfinance Intervention for Patients With Diabetes or Hypertension in Kenya.
   Vedanthan R, Kamano JH, Chrysanthopoulou SA, Mugo R, et al · · 2021 · cited 29× · PMID 33888251 · DOI 10.1016/j.jacc.2021.03.002
2. Human-centered design as a guide to intervention planning for non-communicable diseases: the BIGPIC study from Western Kenya.
   Leung CL, Naert M, Andama B, Dong R, et al · · 2020 · cited 26× · PMID 32398131 · DOI 10.1186/s12913-020-05199-1
3. Bridging Income Generation with Group Integrated Care for cardiovascular risk reduction: Rationale and design of the BIGPIC study.
   Vedanthan R, Kamano JH, Lee H, Andama B, et al · · 2017 · cited 22× · PMID 28577673 · DOI 10.1016/j.ahj.2017.03.012
4. Human-centered implementation research: a new approach to develop and evaluate implementation strategies for strengthening referral networks for hypertension in western Kenya.
   Pillsbury MKM, Mwangi E, Andesia J, Njuguna B, et al · · 2021 · cited 15× · PMID 34479556 · DOI 10.1186/s12913-021-06930-2
5. Cross-sectional analysis of factors associated with medication adherence in western Kenya.
   Gala P, Kamano JH, Vazquez Sanchez M, Mugo R, et al · · 2023 · cited 9× · PMID 37669842 · DOI 10.1136/bmjopen-2023-072358
6. Egocentric social network characteristics and cardiovascular risk among patients with hypertension or diabetes in western Kenya: a cross-sectional analysis from the BIGPIC trial.
   Ruchman SG, Delong AK, Kamano JH, Bloomfield GS, et al · · 2021 · cited 3× · PMID 34475172 · DOI 10.1136/bmjopen-2021-049610
7. Cost-effectiveness of group medical visits and microfinance interventions versus usual care to manage hypertension in Kenya: a secondary modelling analysis of data from the Bridging Income Generation with Group Integrated Care (BIGPIC) trial.
   Chay J, Su RJ, Kamano JH, Andama B, et al · · 2024 · cited 2× · PMID 39030063 · DOI 10.1016/s2214-109x(24)00188-8
8. Human-Centered Implementation Research: A New Approach to Develop and Evaluate Implementation Strategies for Strengthening Referral Networks for Hypertension in western Kenya
   Pillsbury MM, Mwangi E, Andesia J, Njuguna B, et al · · 2021 · DOI 10.21203/rs.3.rs-252907/v2