Bridging Income Generation With Group Integrated Care (BIGPIC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,890
- 试验地点
- 1
- 主要终点
- Change in Systolic Blood Pressure
研究概览
简要总结
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.
详细描述
The Academic Model Providing Access to Healthcare Partnership (AMPATH) was initiated in Kenya in 2001. In 2009, AMPATH was designated as a Center of Excellence for Cardiovascular and Pulmonary Disease Research by the NHLBI, and the program's research portfolio includes CVD, diabetes, and risk factors. Population-based prevalence of diabetes and hypertension in Kenya is not well known, and estimates vary according to technique, definitions, and geography. Prevalence rates range from 1% to 12% for diabetes, and 5% to 24% for hypertension. The lower ranges of these figures are self-reported disease and likely underestimate true prevalence due to low awareness of and screening for chronic diseases in this region.
In response to this substantial and growing burden of diabetes and hypertension, AMPATH has formed a Chronic Disease Management (CDM) Program , and established productive partnerships with the Kenyan government and local communities, in order to optimize care delivery for chronic diseases, such as diabetes and hypertension. AMPATH has a Memorandum of Understanding with the Kenyan Ministry of Public Health and Sanitation and the Ministry of Medical Services to test and evaluate innovative approaches to chronic disease management. The CDM Program developed a robust diabetes and hypertension management protocol derived from the International Diabetes Federation, World Health Organization (WHO), and Joint National Commission 7 and 8 guidelines for diabetes and hypertension management, using drugs contained in the Kenyan national formulary. The CDM program's interventions are delivered at Ministry of Health facilities with associated personnel. In addition, AMPATH has developed innovative, community-based solutions to ensure a consistent and secure supply of essential medicines. The CDM Program has enrolled over 2,000 patients with diabetes and 3,100 patients with hypertension, who are being cared for at nine rural health centers and 30 rural dispensaries. However, achieving BP control has been challenging; preliminary analysis of CDM Program data indicates that despite an average reduction in systolic BP (SBP) of 9.3 mmHg, only 30-40% of the CDM patient population have controlled BP. Thus, the program is actively seeking out innovative approaches to optimize care delivery and outcomes for patients.
AMPATH is also sensitive to the economic reality of its catchment population, recognizing that the average daily income for a substantial proportion of its clients is less than one US dollar per day. AMPATH has created a Safety Net Program to improve the economic security of clients without encouraging dependency, by promoting income-generating activities. The program has conducted preliminary work organizing microfinance groups, initially starting with HIV patients and pregnant women, and recently expanding to patients with diabetes and hypertension. Based on the model of Village-Level Savings and Loan Associations, AMPATH's microfinance program is a client-driven model that involves the creation of community savings groups. Thus, microfinance group members mobilize and manage their own savings, provide interest-bearing loans to group members, offer a limited form of financial insurance, and contribute to a social fund that is used in cases of emergency or welfare issues of group members. AMPATH also provides group members specific training on agribusiness, entrepreneurship, financial literacy, accounting, marketing, and group dynamics, to support engagement in sustainable income-generating activities. Since the program was launched in November 2010, there have been a total of 9,969 clients (83.8% female, 16.2% male), 508 groups, cumulative deposits of over $250,000 and social fund of nearly $23,000. The microfinance program has increased group membership by 14% with a retention rate of over 98%. An impact evaluation of the microfinance program revealed that group members have increased their monthly income by 10% and increased their weekly expenditure on food per household by 18%.
This research project will be conducted within the AMPATH catchment area, in six Divisions in western Kenya, each of which is geographically and administratively divided into Community Units (CUs) of approximately 6,000 individuals: Burnt Forest (4 CUs), Chulaimbo (8), Endebess (4), Kapsara (6), Matunda (4), and Moi's Bridge (6). Each Division has rural health facilities (rural health centers and rural dispensaries) staffed by clinical officers (mid-level practitioners) and nurses, while CHWs are in the villages. There has been a longstanding positive relationship among AMPATH, healthcare providers, and the communities. The CDM program has an established presence in all these communities.
Conceptual Framework Both microfinance and group medical visits can improve health outcomes through many mechanisms. The research team hypothesize that both interventions can cause changes in social network characteristics, leading to improved intermediate factors (diet, physical activity, medication adherence, and retention in care), ultimately yielding CVD risk reduction. It is also possible that both interventions can impact the intermediate factors and health outcomes independent of social network characteristics. Likewise, changes in social network characteristics may mediate the relationship between the interventions and CVD risk reduction independent of the intermediate factors. In addition, the interventions may be related to the health outcomes by other independent pathways. Finally, baseline differences in social network characteristics may moderate the impact of microfinance and group medical visits on CVD risk reduction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Usual Clinical Care (Other)
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.
干预措施: Usual Clinical Care (Other)
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.
干预措施: Microfinance Groups (Other)
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.
干预措施: Group Medical Visits (Other)
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.
干预措施: Group Medical Visits (Other)
结局指标
主要结局
Change in Systolic Blood Pressure
时间窗: Baseline and 12 months
Change in Systolic Blood Pressure at 12 months as compared to baseline
次要结局
- Change in cardiovascular disease (CVD) risk Score(Baseline and 12 months)