Family focused approach to improve heart failure care in lebanon quality (FAMILY) intervention : a randomized controlled trial
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Background: Heart failure is a growing burden globally and Lebanon is no exception. Achieving optimal health outcomes requires adherence to many life-style changes and adaptation of self-management strategies. To date, many theoretical models of self-care have focused on the individual with less intentional focus on caregivers and the socio-cultural factors that impact self-care behaviours, particularly within collectivist cultures. Objectives: To develop a theoretically-informed, culturally-adapted intervention to improve heart failure outcomes tested in a randomised controlled trial (RCT). Methods and design: A series of sequential, interdependent studies contributed to the intervention development tested in a prospective, randomized controlled trial. Phase 1: An integrative review defining the burden of cardiovascular diseases in Lebanon as a guide to the development of a culturally-appropriate intervention. Phase 2: A Systematic review of family involvement in self-care of patients with chronic conditions. Phase 3: Developing a culturally-appropriate, family-centred, nurse-led intervention aimed to improve heart failure outcomes in Lebanon. Phase 4: Translation and validation of the Arabic version of the Self-care of Heart Failure Index (ASCHFI). Phase 5: Evaluation of the intervention through a multi-site RCT assessing all-cause readmission, self-care, quality of life, emergency department presentation, major vascular events, and health care utilization. The intervention group, patients and their primary family caregivers, received a comprehensive educational session on self-care and symptom management and a branded bag with self-care resources, while the control group received the self-care resources only. Results: Phase 1: A total of 28 peer-reviewed articles and 15 reports were identified in this search. Cardiovascular diseases were found to be the leading causes of morbidity and mortality in Lebanon. A range of social, political, economic and cultural factors explain the burden of these diseases including the unique traits of the Lebanese culture such as the narghile smoking and the high rates of familial hypercholesterolemia (Collegian, doi:10.1016/j.colegn.2014.04.004). Phase 2: A total of ten articles addressing family involvement in self-care of patients with chronic conditions were identified. Family-centred approaches were found to be more appropriate in Non-western, collectivist cultures. Outcomes varied based on the type of support provided to different patient populations and on the type and frequency of the interventions. Phase 3: The FAMILY Intervention Heart Failure Model was developed using linguistically and culturally appropriate methods while considering the Lebanese health care sector and the available resources. This model concepts included partnership, collaboration, behaviour change, family unit, empowerment and information sharing (Journal of Advanced Nursing. doi: 10.1111/jan.12768). Phase 4: The A-SCHFI was shown to have enough face and content validity as evaluated by the panel of experts. The three constructs explained 37.5% of the variance with the maintenance construct having the least appropriate loading. The modified A-SCHFI was evaluated to be a valid and reliable measure of self-care in the Lebanese population. Phase 5: The mean age of the 256 patients was 67 (SD=8) years and 55% were male; most caregivers were the patients’ spouse (43%). Readmission was significantly lower in the intervention group compared to the control group (n=10, 33% vs. n=20, 67%, p<0.05 respectively) at one month follow up. Self-care scores, lower at baseline, improved at 30 days with significant improvement in the intervention group over the control group in both the maintenance and confidence scales (67 (SD=14) vs. 58 (SD=19), (p=0.0001) and 64 (SD=20) vs. 55 (SD=22), (p=0.002) respectively). No changes were noted in quality of life scores or emergency department presentations between the groups. Significantly more participants in the control group needed health care facilities than in the intervention group (n=24 (23%) vs. n=12 (11%) respectively, p<0.05) at follow up. Three cases of major vascular events were noted in the control group but none in the intervention group. Conclusion: As the burden of chronic diseases increases globally, particularly in emerging economies, developing models of intervention that are appropriate to the socio-cultural context are necessary. In addition, implementation of valid and reliable outcome measures is warranted. Future research on family involvement through multi-session educational conferences and longer follow-up periods are warranted.
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