The long-term effects of Kerala Diabetes Prevention Program on diabetes incidence and cardiometabolic risk: a study protocol.

INTRODUCTION: India currently has more than 74.2 million people with Type 2 Diabetes Mellitus (T2DM). This is predicted to increase to 124.9 million by 2045. In combination with controlling blood glucose levels among those with T2DM, preventing the onset of diabetes among those at high risk of developing it is essential. Although many diabetes prevention interventions have been implemented in resource-limited settings in recent years, there is limited evidence about their long-term effectiveness, cost-effectiveness, and sustainability. Moreover, evidence on the impact of a diabetes prevention program on cardiovascular risk over time is limited. OBJECTIVES: The overall aim of this study is to evaluate the long-term cardiometabolic effects of the Kerala Diabetes Prevention Program (K-DPP). Specific aims are 1) to measure the long-term effectiveness of K-DPP on diabetes incidence and cardiometabolic risk after nine years from participant recruitment; 2) to assess retinal microvasculature, microalbuminuria, and ECG abnormalities and their association with cardiometabolic risk factors over nine years of the intervention; 3) to evaluate the long-term cost-effectiveness and return on investment of the K-DPP; and 4) to assess the sustainability of community engagement, peer-support, and other related community activities after nine years. METHODS: The nine-year follow-up study aims to reach all 1007 study participants (500 intervention and 507 control) from 60 randomized polling areas recruited to the original trial. Data are being collected in two phases. In phase 1 (Survey), we are admintsering a structured questionnaire, undertake physical measurements, and collect blood and urine samples for biochemical analysis. In phase II, we are inviting participants to undergo retinal imaging, body composition measurements, and ECG. All data collection is being conducted by trained Nurses. The primary outcome is the incidence of T2DM. Secondary outcomes include behavioral, psychosocial, clinical, biochemical, and retinal vasculature measures. Data analysis strategies include a comparison of outcome indicators with baseline, and follow-up measurements conducted at 12 and 24 months. Analysis of the long-term cost-effectiveness of the intervention is planned. DISCUSSION: Findings from this follow-up study will contribute to improved policy and practice regarding the long-term effects of lifestyle interventions for diabetes prevention in India and other resource-limited settings. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry-(updated from the original trial)ACTRN12611000262909; India: CTRI/2021/10/037191.

Exploring Factors Affecting Health Care Providers' Behaviors for Maintaining Continuity of Care in Kerala, India; A Qualitative Analysis Using the Theoretical Domains Framework.

Introduction: Access to patients' documented medical information is necessary for building the informational continuity across different healthcare providers (HCP), particularly for patients with non-communicable diseases (NCD). Patient-held health records (PHR) such as NCD notebooks have important documented medical information, which can contribute to informational continuity in the outpatient settings for patients with diabetes and hypertension in Kerala. We aimed to use the theoretical domains framework (TDF) to identify the perceived HCP factors influencing informational and management continuity for patients with diabetes and hypertension. Methods: We re-analyzed semi-structured interview data for 17 HCPs with experience in the NCD programme in public health facilities in Kerala from a previous study, using the TDF. The previous study explored patients, carers and HCPs experiences using PHRs such as NCD notebooks in the management of diabetes and hypertension. Interview transcripts were deductively coded based on a coding framework based on the 14 domains of TDF. Specific beliefs were generated from the data grouped into the domains. Results: Data were coded into the 14 domains of TDF and generated 33 specific beliefs regarding maintaining informational and management continuity of care. Seven domains were judged to be acting as facilitators for recording in PHRs and maintaining continuity. The two domains "memory, attention and decision process" and "environmental context and resources" depicted the barriers identified by HCPs for informational continuity of care. Conclusion: In this exploration of recording and communicating patients' medical information in PHRs for patients with diabetes and hypertension, HCPs attributions of sub-optimal recording were used to identify domains that may be targeted for further development of supporting intervention. Overall, nine domains were likely to impact the barriers and facilitators for HCPs in recording in PHRs and communicating; subsequently maintaining informational and management continuity of care. This study showed that many underlying beliefs regarding informational continuity of care were based on HCPs' experiences with patient behaviors. Further research is needed for developing the content and appropriate support interventions for using PHRs to maintain informational continuity.

Perceived facilitators and barriers of enrolment, participation and adherence to a family based structured lifestyle modification interventions in Kerala, India: A qualitative study.

Background: The objective of the study was to describe participants' and providers' perspectives of barriers and facilitators of enrolment, participation and adherence to a structured lifestyle modification (SLM) interventions as part of the PROLIFIC trial in Kerala, India. Methods: Family members who had been enrolled for 12-months or more in a family-based cardiovascular risk reduction intervention study (PROLIFIC Trial) were purposively sampled and interviewed using a semi-structured guide. The non-physician health workers (NPHWs) delivering the intervention were also interviewed or included in focus groups (FGDs). Thematic analysis was used for data analysis. Results: In total, 56 in-depth interviews and three FGDs were conducted. The descriptive themes emerged were categorised as (a) motivation for enrolment and engagement in the SLM interventions, (b) facilitators of adherence, and (c) reasons for non-adherence. A prior knowledge of familial cardiovascular risk, preventive nature of the programme, and a reputed organisation conducting the intervention study were appealing to the participants. Simple suggestions of healthier alternatives based on existing dietary practices, involvement of the whole family, and the free annual blood tests amplified the adherence. Participants highlighted regular monitoring of risk factors and provision of home-based care by NPHWs as facilitators for adherence. Furthermore, external motivation by NPHWs in setting and tracking short-term health goals were perceived as enablers of adherence. Nonetheless, home makers expressed difficulty in dealing with varied food choices of family members. Young adults in the programme noted that dietary changes were affected by eating out as they wanted to fit in with peers. Conclusions: The findings suggest that a family-based, trained healthcare worker led SLM interventions are acceptable in Kerala. Increasing the number of visits by NPHWs, regular monitoring and tracking of lifestyle goals, and targeting young adults and children for dietary changes may further improve adherence to SLM interventions.

Tobacco Cessation Among Acute Coronary Syndrome Patients in Kerala, India: Patient and Provider Perspectives.

Tobacco cessation is an important intervention to reduce mortality from ischemic heart disease, the leading cause of death in India. In this study, we explored facilitators, barriers, and cultural context to tobacco cessation among acute coronary syndrome (ACS, or heart attack) patients and providers in a tertiary care institution in the south Indian state of Kerala, with a focus on patient trajectories. Patients who quit tobacco after ACS expressed greater understanding about the link between tobacco and ACS, exerted more willpower at the time of discharge, and held less fatalistic beliefs about their health compared to those who continued tobacco use. The former were motivated by the fear of recurrent ACS, strong advice to quit from providers, and determination to survive and financially provide for their families. Systemic barriers included inadequate training, infrequent prescription of cessation pharmacotherapy, lack of ancillary staff to deliver counseling, and stigma against mental health services.

A PROgramme of Lifestyle Intervention in Families for Cardiovascular risk reduction (PROLIFIC Study): design and rationale of a family based randomized controlled trial in individuals with family history of premature coronary heart disease.

BACKGROUND: Recognizing patterns of coronary heart disease (CHD) risk in families helps to identify and target individuals who may have the most to gain from preventive interventions. The overall goal of the study is to test the effectiveness and sustainability of an integrated care model for managing cardiovascular risk in high risk families. The proposed care model targets the structural and environmental conditions that predispose high risk families to development of CHD through the following interventions: 1) screening for cardiovascular risk factors, 2) providing lifestyle interventions 3) providing a framework for linkage to appropriate primary health care facility, and 4) active follow-up of intervention adherence. METHODS: Initially, a formative qualitative research component will gather information on understanding of diseases, barriers to care, specific components of the intervention package and feedback on the intervention. Then a cluster randomized controlled trial involving 740 families comprising 1480 participants will be conducted to determine whether the package of interventions (integrated care model) is effective in reducing or preventing the progression of CHD risk factors and risk factor clustering in families. The sustainability and scalability of this intervention will be assessed through economic (cost-effectiveness analyses) and qualitative evaluation (process outcomes) to estimate value and acceptability. Scalability is informed by cost-effectiveness and acceptability of the integrated cardiovascular risk reduction approach. DISCUSSION: Knowledge generated from this trial has the potential to significantly affect new programmatic policy and clinical guidelines that will lead to improvements in cardiovascular health in India. TRIAL REGISTRATION NUMBER: NCT02771873, registered in May 2016 ( https://clinicaltrials.gov/ct2/show/results/NCT02771873 ).