Development and pilot testing of health worker delivered theory of planned behaviour based educational intervention for behaviour change in chronic respiratory disease patients : a feasibility study in southern Indian rural community

INTRODUCTION: Chronic respiratory diseases (CRDs) are one of the major causes of mortality and morbidity worldwide. Low- and middle-income countries (LMICs) account for 80% of the total burden of CRDs and mortality. CRDs are the second most common cause of all deaths in India and contributed to almost 30% of all deaths and DALYs due to CRDs globally in 2019. Most of these chronic diseases including CRDs are related to risk behaviours and therefore modifying health behaviours are crucial in improving chronic diseases outcomes, with the potential to reduce the enormous morbidity and mortality associated with such diseases. The Theory of Planned Behaviour (TPB) had been used extensively, mostly in western countries and in affluent populations to predict health behaviour or deliver interventions to change health behaviour. The research in my thesis was designed to test the feasibility of implementing a TPB-based health intervention in changing health behaviour, using health care workers (HCWs), in a rural, low literacy population. AIM AND OBJECTIVES: The aim of my research project was to develop and pilot test HCW-delivered TPB-based health intervention for behaviour change in patients with chronic respiratory disease (CRD) using current evidence in practice and drawing on past experience of delivering culturally sensitive health programmes adapted for low health literacy communities. The objectives were - 1) To examine the effect of TPB-based interventions in chronic diseases in low health literacy settings through a systematic review of literature 2) To develop a culturally acceptable and locally adaptable TPB-based intervention model for behaviour change in patients with chronic respiratory disease 3) To examine through a feasibility study, whether successful outcomes of TBP-based interventions found in the literature could be reproduced in a low-resource setting, and identify the implementation challenges in these settings. METHODS: My research methods were informed by the new UK Medical Research Council (MRC) guidance and update 2019 for developing and evaluating complex interventions; they included identifying evidence, developing/identifying a theory, modelling processes and outcomes (intervention development), feasibility testing, evaluation and implementation (dissemination of findings). The research work proceeded in four phases - 1.I began studying the existing evidence through a systematic review of literature, following Cochrane review methods. The review examined the feasibility and effectiveness of TPB-based interventions on chronic disease patients to change health behaviour, particularly in low health literate populations of LMICs. I used a Population, Intervention, Comparison, Outcome and Study design (PICOS) search strategy and duplicate screening, data extraction and Cochrane Collaboration tool for quality assessment. Narrative synthesis was conducted due to heterogeneity of studies. 2.In the second phase I conducted formative qualitative research in my target population to examine prevailing attitudes, subjective norms perceived behavioural control and underlying beliefs related to CRDs - while exploring the experiences of those living with the disease. Qualitative data were collected between September and December 2018 through eight focus group discussions (FGDs), five in-depth interviews and four key-informant interviews from patients and community members. Community engagement and awareness-raising was undertaken prior to the study and all interviews and discussions were recorded with permission. Inductive coding was used to thematically analyse the results. 3.In the third phase, I developed the intervention by modelling processes and outcomes. A TPB-based evaluation questionnaire was developed with guidance from the results of the formative research, it was validated by pilot testing, content validity and reliability. Development of the methods and intervention took account of cultural sensitivity and the local customs. The intervention was refined using the Template for Intervention Description and Replication (TIDieR) checklist and guide. 4.In the final phase I tested the intervention for its feasibility and effectiveness using a cluster randomised design. Four of the 18 clusters from the 'community development block' (administrative unit of government in the local community) where our hospital is situated, were chosen for the intervention with two in the intervention arm and two in the control. 100 patients with confirmed CRD (asthma, COPD, bronchiectasis, post tuberculosis lung disease) were recruited in each arm of the study. Patients in both arms were provided with free inhalers with spacers, training on breathing exercises and some basic education materials on CRDs. In the intervention arm, patients received TPB-based educational intervention using culturally acceptable media and methods; some created with suggestions from patients and community members. The TPB constructs (attitude towards behaviour, subjective norms, perceived behavioural control and intention) were evaluated at baseline and at the end of the intervention period - health behaviour and clinical outcomes were also measured. RESULTS: 1.My systematic review's search strategy produced 4284 studies of which four were included for narrative synthesis. Among the four studies, the intervention period was between four months to one year, they were from LMIC settings, and all were conducted in urban populations. The review findings suggested TPB-based psychological theory could be effectively applied in these LMIC settings and suggested interventions based on TBP theory were feasible - although only a few such studies were identified and interventions were typically of a shorter duration (~4-5 months). TPB-based interventions were undertaken for chronic diseases including osteoarthritis, diabetes mellitus and cardiovascular diseases (myocardial infarction), but no such study was identified for chronic respiratory disease. Two of the studies specifically described formative research before undertaking a TPB-based intervention. 2.The formative qualitative research elicited important beliefs, perceptions, attitudes, norms and behaviours prevailing in this local community. There was generally poor understanding of the diseases or their causation; health seeking behaviour commonly involved conventional health services, but many sought treatment directly from pharmacies for symptomatic relief and/or alternative/traditional health providers; common treatment modalities were oral medicines for symptom relief in less severe conditions (contrary to accepted practice) and use of injections and nebulisations for emergencies and relief of severe symptoms. Prevailing risk behaviours for CRD included smoking and use of biomass fuel, which were common in the community, the former particularly among males and latter in households - for cooking. The use of inhalers was infrequent and inadequate, mainly for immediate and symptomatic relief. There was no awareness or practice of respiratory exercises among patients with CRD; health providers typically gave no advice on the topic, and associated facilities were rarely accessed by participants. 3.The evaluation questionnaire (Appendix 13) developed for baseline and post-intervention assessment had four sections - identifying information, socio-demographic information, the TPB questionnaire and the HBM questionnaire. The TPB questionnaire had a total of 61 questions with 31 questions on intention, attitude, subjective norm and perceived behavioural control and the rest on their underlying beliefs. The screening questionnaire for health care workers (HCWs), the Clinical Assessment and Review form and the TPB intervention were designed and developed as part of my project (embedded within a larger feasibility trial). The TPB intervention comprised motivational videos, 'ask your doctor' videos about asthma and COPD, a calendar showing steps of inhaler use and breathing exercises, puppet shows answering frequently asked questions in form of a play, a school painting competition on CRDs and engaging the patients and the public through interaction with doctors and other health providers. 4.The two objectives of this phase were: pilot testing the intervention for its feasibility and implementation challenges; and evaluation of the effectiveness of the TPB intervention. The overall screening rate by the HCWs was 52.8%, the confirmation rate among the screened participants was 91.3% and all the confirmed patients of CRD could be recruited. The early dropout rate was 4.5% (after recruitment and before start of intervention) and the final completion rate at the end of one year of intervention was 89%. Health workers involved in the project were capable of all key project elements, including screening, health education and follow-up. There was significant improvement in the constructs of TPB (attitudes, subjective norms, perceived behavioural control) and in CRD-related health behaviour at the end of intervention period - however this was seen in both intervention and control arm. There was significant improvement in adherence to inhalers (from 78% to 94%, p<0.001) and in symptoms (cough, phlegm and breathlessness) post intervention. Episodes of exacerbations decreased dramatically (p<.001) and lung function remained static or improved in 69.6% of the patients.