Process evaluation of a pragmatic implementation trial to support self-management for the prevention and management of type 2 diabetes in Uganda, South Africa and Sweden in the SMART2D project.

INTRODUCTION: Type 2 diabetes (T2D) and its complications are increasing rapidly. Support for healthy lifestyle and self-management is paramount, but not adequately implemented in health systems. Process evaluations facilitate understanding why and how interventions work through analyzing the interaction between intervention theory, implementation and context. The Self-Management and Reciprocal Learning for Type 2 Diabetes project implemented and evaluated community-based interventions (peer support program; care companion; and link between facility care and community support) for persons at high risk of or having T2D in a rural community in Uganda, an urban township in South Africa, and socioeconomically disadvantaged urban communities in Sweden. RESEARCH DESIGN AND METHODS: This paper reports implementation process outcomes across the three sites, guided by the Medical Research Council framework for complex intervention process evaluations. Data were collected through observations of peer support group meetings using a structured guide, and semistructured interviews with project managers, implementers, and participants. RESULTS: The countries aligned implementation in accordance with the feasibility and relevance in the local context. In Uganda and Sweden, the implementation focused on peer support; in South Africa, it focused on the care companion part. The community-facility link received the least attention. Continuous capacity building received a lot of attention, but intervention reach, dose delivered, and fidelity varied substantially. Intervention-related and context-related barriers affected participation. CONCLUSIONS: Identification of the key uncertainties and conditions facilitates focus and efficient use of resources in process evaluations, and context relevant findings. The use of an overarching framework allows to collect cross-contextual evidence and flexibility in evaluation design to adapt to the complex nature of the intervention. When designing interventions, it is crucial to consider aspects of the implementing organization or structure, its absorptive capacity, and to thoroughly assess and discuss implementation feasibility, capacity and organizational context with the implementation team and recipients. These recommendations are important for implementation and scale-up of complex interventions. TRIAL REGISTRATION NUMBER: ISRCTN11913581.

Prevention and management of type 2 diabetes mellitus in Uganda and South Africa: Findings from the SMART2D pragmatic implementation trial.

Health systems in many low- and middle-income countries are struggling to manage type 2 diabetes (T2D). Management of glycaemia via well-organized care can reduce T2D incidence, and associated morbidity and mortality. The primary aim of this study was to evaluate the effectiveness of facility plus community care interventions (integrated care), compared to facility only care interventions (facility care) towards improvement of T2D outcomes in Uganda and South Africa. A pragmatic cluster randomized trial design was used to compare outcomes among participants with T2D and those at high risk. The trial had two study arms; the integrated care arm, and the facility care arm; and in Uganda only, an additional usual care arm. Participants were enrolled at nine primary health facilities in Uganda, and two in South Africa. Participants were adults aged 30 to 75 years, and followed for up to 12 months. Primary outcomes were glycaemic control among participants with T2D, and reduction in HbA1c > = 3 mmol/mol among participants at high risk. Secondary outcomes were retention into care and incident T2D. Adjusted analysis revealed significantly higher retention into care comparing integrated care and facility care versus usual care in Uganda and integrated care versus facility care in South Africa. The effect was particularly high among participants at high risk in Uganda with an incident rate ratio of 2.46 [1.33-4.53] for the facility care arm and 3.52 [2.13-5.80] for the integrated care arm. No improvement in glycaemic control or reduction in HbA1c was found in either country. However, considerable and unbalanced loss to follow-up compromised assessment of the intervention effect on HbA1c. Study interventions significantly improved retention into care, especially compared to usual care in Uganda. This highlights the need for adequate primary care for T2D and suggest a role for the community in T2D prevention. Trial registration number: ISRCTN11913581.

SMART2D-development and contextualization of community strategies to support self-management in prevention and control of type 2 diabetes in Uganda, South Africa, and Sweden.

Type 2 diabetes (T2D) and its complications are increasing rapidly in low- and middle-income countries, as well as among socioeconomically disadvantaged populations in high-income countries. Support for healthy lifestyle and self-management is paramount but not well implemented in health systems, and there is need for knowledge on how to design and implement interventions that are contextualized and patient centered and address special needs of disadvantaged population groups. The SMART2D project implements and evaluates a lifestyle and self-management intervention for participants recently diagnosed with or being at increased risk for T2D in rural communities in Uganda, an urban township in South Africa, and socioeconomically disadvantaged urban communities in Sweden. Our aim was to develop an intervention with shared key functions and a good fit with the local context, needs, and resources. The intervention program design was conducted in three steps facilitated by a coordinating team: (a) situational analysis based on the SMART2D Self-Management Framework and definition of intervention objectives and core strategies; (b) designing generic tools for the strategies; and (c) contextual translation of the generic tools and their delivery. This article focuses on community strategies to strengthen support from the social and physical environment and to link health care and community support. Situational analyses showed that objectives and key functions addressing mediators from the SMART2D framework could be shared. Generic tools ensured retaining of functions, while content and delivery were highly contextualized. Phased, collaborative approach and theoretical framework ensured that key functions were not lost in contextualization, also allowing for cross-comparison despite flexibility with other aspects of the intervention between the sites. The trial registration number of this study is ISRCTN11913581.

Adapting the Diabetes Prevention Program for low- and middle-income countries: preliminary implementation findings from lifestyle Africa.

Rates of cardiovascular disease and diabetes are rising in low- and middle-income countries (LMIC), but there is a dearth of research devoted to developing and evaluating chronic disease interventions in these settings, particularly in Africa. Lifestyle Africa is a novel, culturally adapted version of the Diabetes Prevention Program (DPP) being evaluated in an ongoing community-based cluster-randomized trial in an underresourced urban community in South Africa. The purpose of this study is to describe the adaptations and adaptation process used to develop the program and to report preliminary implementation findings from the first wave of groups (n = 11; 200 individuals) who participated in the intervention. The RE-AIM model and community advisory boards guided the adaptation process. The program was designed to be delivered by community health workers (CHWs) through video-assisted sessions and supplemented with text messages. Participants in the trial were overweight and obese members of existing chronic disease "support groups" served via CHWs. Implementation outcomes included completion of sessions, session attendance, fidelity of session delivery, and participant satisfaction. Results indicated that 10/11 intervention groups completed all 17 core sessions. Average attendance across all sessions and groups was 54% and the percentage who attended at least 75% of sessions across all groups was 35%. Fidelity monitoring indicated a mean of 84% of all required procedures were completed while overall communication skills were rated as "good" to "excellent". These preliminary results support the feasibility of culturally adapting the DPP for delivery by CHWs in underresourced settings in LMIC.