Process evaluation of a randomised controlled trial of a pharmacological strategy to improve hypertension control: Protocol for a qualitative study

© 2018 Author(s) (or their employer(s)). Introduction Globally, the prevalence of uncontrolled hypertension is high, particularly in low- and middle-income countries. There is a critical need for strategies to improve hypertension control. The early use of a fixed low-dose combination of three antihypertensive drugs (triple pill) has the potential to significantly improve hypertension control. The TRI ple Pill vs. U sual care M anagement for P atients with mild-to- moderate H ypertension (TRIUMPH) randomised controlled trial (RCT) is designed to test the effects of this strategy compared with usual care in patients with mild-to-moderate hypertension. This paper reports the protocol of a process evaluation of the TRIUMPH RCT. The objectives are to understand factors related to implementation of the intervention, mechanisms of effect, contextual factors that underpin the effectiveness of the triple pill strategy and the potential barriers and facilitators to implementing the strategy in clinical practice. Methods and analysis Face-to-face semistructured in-depth interviews with a purposive sample of TRIUMPH RCT participants and healthcare professionals in Sri Lanka will be conducted. Healthcare professionals will include physicians and their staff who were involved in conducting the TRIUMPH RCT. Interviewees will be recruited sequentially until thematic saturation is achieved. Interviews will be audio recorded, transcribed verbatim and analysed in NVivo using framework analysis methods. Ethics and dissemination The TRIUMPH RCT and process evaluation have received approval from the relevant Ethics Review Committee. All participants will be asked to provide written consent before participation. Findings from the study will be disseminated through publications and conference presentations

Measuring mental well-being in Sri Lanka : validation of the Warwick Edinburgh Mental Well-being Scale (WEMWBS) in a Sinhala speaking community

Background: Well-being is an important aspect of people’s lives and can be considered as an index of social progress. The Warwick Edinburgh Mental Well-being scale (WEMWBS) was developed to capture subjective mental well-being. It is a widely tested measure of mental well-being at the population level and has 14 items and a short-form with 7 items. This study was carried out to culturally validate and adapt the WEMWBS among a Sinhala speaking population in Sri Lanka. Methods: A forward and backward translation of the scale into Sinhala was done followed by a cognitive interview. The translated and culturally adapted scale and other mental health scales were administered to a sample of 294 persons between the ages of 17–73 using a paper-based version (n = 210) and an online survey (n = 84). Internal consistency reliability and test–retest reliability were tested. Construct validity, and convergent and discriminant validity were assessed using the total sample. Results: The translated questionnaire had good face and content validity. Internal consistency reliability was 0.91 and 0.84 for the 14-item and 7-item scales, respectively. Test–retest reliability over two weeks was satisfactory (Spearman r = 0.72 p < 0.001). Confirmatory factor analysis supported a one factor model. Convergent validity was assessed using WHO-5 well-being index (Spearman r = 0.67, p < 0.001), Patient Health Questionnaire (PHQ-9) (Spearman r = (-0.45), p < 0.001) and Kessler psychological distress scale (K10) (Spearman r = (-0.55), p < 0.001). Conclusions: The translated and culturally adapted Sinhala version of the WEMWBS has acceptable psychometric properties to assess mental well-being at the population level among the Sinhala speaking population in Sri Lanka

Translational research for diabetes self-management in Sri Lanka: a randomized controlled trial

Aims: The study tested the hypothesis that a theory driven Diabetes Self-Management (DSM)intervention delivered by trained nurses would result in a clinically significant improvement in glycaemic control. Methods: Patients with an HbA1c >7.5% (58 mmol/mol) and free of diabetes complications were enrolled into a randomized controlled trial (n = 85). Intervention consisted of four sessions and monthly follow up for 6 months. Biochemical tests, and diet and physical activity assessments were done in both groups. Analysis of covariance was used to test the effectiveness of the intervention. Results: At 6 months, there was a significant difference (P = 0.001) in HbA1c between the groups controlling for baseline values and other variables. Based on the primary outcome,28% in the intervention group achieved the target value of 6.5% HbA1c, compared to 8% in the “usual care” group (P < 0.001; η² = 0.65). The reduction in total energy intake and increase in physical activity was significant in the intervention group between baseline and follow up

Feasibility of a Lifestyle Intervention Program for Prevention of Diabetes Among Women With Prior Gestational Diabetes Mellitus (LIVING Study) in South Asia: A Formative Research Study.

Aim: To refine and contextually adapt a postpartum lifestyle intervention for prevention of type 2 diabetes mellitus (T2DM) in women with prior gestational diabetes mellitus (GDM) in Bangladesh, India, and Sri Lanka. Materials and Methods: In-depth interviews (IDIs) and focus group discussions (FGDs) were conducted with women with current diagnosis of GDM, and health care professionals involved in their management, to understand relevant local contextual factors for intervention optimization and implementation. This paper describes facilitators and barriers as well as feedback from participants on how to improve the proposed intervention. These factors were grouped and interpreted along the axes of the three main determinants of behavior-capability, opportunity, and motivation. IDIs and FGDs were digitally recorded, transcribed, and translated. Data-driven inductive thematic analysis was undertaken to identify and analyze patterns and themes. Results: Two interrelated themes emerged from the IDIs and FGDs: (i) The lifestyle intervention was acceptable and considered to have the potential to improve the existing model of care for women with GDM; and (ii) Certain barriers such as reduced priority of self-care, and adverse societal influences postpartum need to be addressed for the improvement of GDM care. Based on the feedback, the intervention was optimized by including messages for family members in the content of the intervention, providing options for both text and voice messages as reminders, and finalizing the format of the intervention session delivery. Conclusion: This study highlights the importance of contextual factors in influencing postpartum care and support for women diagnosed with GDM in three South Asian countries. It indicates that although provision of postpartum care is complex, a group lifestyle intervention program is highly acceptable to women with GDM, as well as to health care professionals, at urban hospitals