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Bridging Income Generation With Group Integrated Care (BIGPIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02501746
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : June 17, 2020
Sponsor:
Collaborators:
Moi University College of Health Sciences
Brown University
Duke University
Purdue University
National Heart, Lung, and Blood Institute (NHLBI)
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
NYU Langone Health

Brief 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.


Condition or disease Intervention/treatment Phase
Cardiovascular Disease Diabetes Other: Usual Clinical Care Other: Group Medical Visits Other: Microfinance Groups Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2890 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Bridging Income Generation With Group Integrated Care (BIGPIC)
Actual Study Start Date : February 6, 2017
Actual Primary Completion Date : December 29, 2019
Actual Study Completion Date : December 29, 2019

Arm Intervention/treatment
Active Comparator: Usual Clinical Care (UC)
This will be the current standard of care delivered by the AMPATH CDM Program, in accordance with the management protocol for diabetes and hypertension.
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 Name: UC

Experimental: Usual clinical care plus microfinance groups only (MF)
Usual clinical care as described above. In addition, participants will be encouraged to create microfinance groups organized and supported by AMPATH's Safety Net Program.
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 Name: UC

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.
Other Name: MF

Experimental: Group medical visits only (GMV)
Participants randomized to this arm will be invited to create a group that will attend monthly group medical visits at the rural health facility. Each group medical visit will be staffed by both the rural clinician and the local CHW (educator). Groups will consist of the same patients at each of 12 monthly visits. Each visit will begin with the measurement of fasting blood glucose and resting electronic BP, as well as the ascertainment of medication regimens for BP and diabetes, and extent of adherence to the prescribed regimen.
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 Name: GMV

Experimental: GMV integrated into GMV-MF
Clinical care will be provided in the form of group medical visits, and the participants will be actively recruited to create microfinance groups. Thus, the monthly group medical visit will be integrated into the microfinance groups, wherein the visit will consist of an initial microfinance portion, followed by the group medical visit.
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 Name: GMV




Primary Outcome Measures :
  1. Change in Systolic Blood Pressure [ Time Frame: Baseline and 12 months ]
    Change in Systolic Blood Pressure at 12 months as compared to baseline


Secondary Outcome Measures :
  1. Change in cardiovascular disease (CVD) risk Score [ Time Frame: Baseline and 12 months ]
    Change in overall CVD risk as measured by the QRISK2 score, which has been validated for calculating 10-year CVD event risk for Black Africans.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Adults in the CDM Program who:

  • Have diabetes (fasting glucose ≥ 7 mmol/L);
  • Are at increased risk for developing diabetes (impaired fasting glucose (fasting glucose 5.6 - 6.9 mmol/L);
  • Have an elevated Leicester Risk Assessment score (≥ 7)

Exclusion criteria:

  • Acute illness requiring immediate medical attention;
  • Terminal illness;
  • Refusal to provide informed consent;
  • Individuals who are pregnant or have HIV will be excluded, (automatically referred to a higher level of care within the AMPATH care system).

Participation in the trial will not be contingent upon membership in a group. An intention-to-treat analysis will be conducted and the denominator in each cluster will include all eligible individuals who consent, irrespective of whether they are in a group, thus minimizing selection bias.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501746


Locations
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Kenya
Moi University College of Health Sciences
Eldoret, Kenya
Sponsors and Collaborators
NYU Langone Health
Moi University College of Health Sciences
Brown University
Duke University
Purdue University
National Heart, Lung, and Blood Institute (NHLBI)
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Rajesh Vedanthan, MD, MPH NYU Langone Health
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02501746    
Other Study ID Numbers: 18-01260
1R01HL125487 ( U.S. NIH Grant/Contract )
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Group medical care
Microfinance
Hypertension
Community-based intervention
Global health
Additional relevant MeSH terms:
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Cardiovascular Diseases