RESUMO
Background: Heart failure (HF) is a debilitating condition associated with enormous public health burden. Management of HF is complex as it requires care-coordination with different cadres of health care providers. We propose to develop a team based collaborative care model (CCM), facilitated by trained nurses, for management of HF with the support of mHealth and evaluate its acceptability and effectiveness in Indian setting. Methods: The proposed study will use mixed-methods research. Formative qualitative research will identify barriers and facilitators for implementing CCM for the management of HF. Subsequently, a cluster randomised controlled trial (RCT) involving 22 centres (tertiary-care hospitals) and more than 1500 HF patients will be conducted to assess the efficacy of the CCM in improving the overall survival as well as days alive and out of hospital (DAOH) at two-years (CTRI/2021/11/037797). The DAOH will be calculated by subtracting days in hospital and days from death until end of study follow-up from the total follow-up time. Poisson regression with a robust variance estimate and an offset term to account for clustering will be employed in the analyses of DAOH. A rate ratio and its 95% confidence interval (CI) will be estimated. The scalability of the proposed intervention model will be assessed through economic analyses (cost-effectiveness) and the acceptability of the intervention at both the provider and patient level will be understood through both qualitative and quantitative process evaluation methods. Potential Impact: The TIME-HF trial will provide evidence on whether a CCM with mHealth support is effective in improving the clinical outcomes of HF with reduced ejection fraction in India. The findings may change the practice of management of HF in low and middle-income countries.
RESUMO
Background: Heart failure (HF) is a multi-morbid chronic condition, which adversely affects the quality of life of the affected individual. Engaging the patient and their caregivers in self-care is known to reduce mortality, rehospitalisation and improve quality of life among HF patients. The PACT-HF trial will answer whether clinical benefits in terms of mortality and hospitalisation outcomes can be demonstrated by using a pragmatic design to explore the specific effects of physical activity, and cognitive behavioural therapy in HF patients in India. Methods: We will conduct a 2 × 2 factorial, randomized, open-label trial, which aims to see if rehabilitation strategies of structured physical activity training and cognitive behavioural therapy for depression and self-management reduce the risk of repeat hospitalisation and deaths in HF patients in India. Patients will be randomised to (1) physical activity + usual care (2) cognitive behaviour therapy + usual care, (3) physical activity + cognitive behaviour therapy + usual care, and (4) usual care at 1:1:1:1 ratio. Time to mortality will be the primary outcome. A composite of mortality and hospitalisation for HF will be the main secondary outcome. Additional secondary outcomes will include 'days alive and out of hospital', cumulative hospitalisation, quality of life, Minnesota Living with Heart Failure questionnaire score, depression score, six minutes walking distance, handgrip strength, and adherence to medicines and lifestyle. The effects of intervention on the primary outcome will be estimated from Cox proportional hazard models. For the continuous secondary outcome variables, differences between randomised groups will be estimated from linear mixed models or generalised estimating equations (GEE) as appropriate. Discussion: PACT-HF is designed to provide reliable evidence about the balance of benefits and risks conferred by physical activity and cognitive behavioural therapy-based cardiac rehabilitation for those with HF, irrespective of their initial disease severity.
RESUMO
Background: Despite the availability of effective drugs, blood pressure (BP) control rate is sub-optimal in individuals with hypertension in low- and middle-income countries (LMICs). The role of self-care in the management of BP is less studied in LMIC settings. Methods: We conducted a community-based, cross-sectional study in individuals with hypertension in Kollam district, Kerala. A multistage cluster sampling method was used for the selection of study participants. We measured self-care by using an adapted Hypertension Self-Care Activity Level Effects (H-SCALE) scale. Descriptive statistics were used to summarise the data and logistic regression analysis was conducted to identify factors associated with BP control. Results: In total, 690 individuals with hypertension (women=60%) and a mean age of 57±8 years participated in the study. More than half (54%) of the participants were adherent to anti-hypertensive medications. However, the adherence rate was much lower for the dietary approach to stop hypertension (DASH) diet (12.8%), recommended level of physical activity (24%) and weight management (11.4%). Overall BP control was achieved in two of five individuals (38.4%, 95% CI: 34.7-42.0%). Among self-care activities, adherence to medications (AOR: 1.8, 95% CI: 1.3-2.5), DASH diet (AOR: 1.5, 95% CI: 1.0-2.4), and non-smoking status (AOR: 3.3, 95% CI: 1.7-6.4) were associated with control of BP. Additionally, good family support to self-care (AOR: 1.9, 95% CI: 1.1-3.1) was associated with better control of BP. Conclusion: In individuals with hypertension, the BP control rate is achieved in two of five individuals. Adoption of self-care activities are sub-optimal. Both family support and adherence to self-care activities are associated with BP control. Family based interventions to improve adherence to self-care activities could have a significant public health impact in achieving better population-level BP control rates in Kerala, India.