Title: Developing a Complex Intervention for the Treatment of Orthostatic Hypotension in Older People
Funder: Department of Health and Social Care

Abstract: Background Orthostatic hypotension (OH) is an abnormal drop in blood pressure (BP), occurring on standing from a recumbent position. It is associated with a reduction in quality of life and an increase in mortality. As OH is implicated in 25-50% of all falls, it is associated with 0.5-1 billion of the 2 billion annual NHS cost of falls. It is largely a condition of older people, affecting 30% in the community and 70% in long-term care. Evidence for its treatment is poor with existing studies being small and of low quality. With 86% of UK Geriatricians surveyed requesting more evidence, and the UK Government prioritising the improvement of care and services for the rapidly expanding older population, developing effective treatments for OH is timely. Aims Develop a complex intervention, of non-drug therapies, for older people with OH that is acceptable, relevant and achievable. Methods Work Package (WP) 1: Identifying existing evidence and defining current practice. Systematic review of non-drug therapies will identify existing evidence, providing a framework of therapies worthy of further evaluation. Therapies may include bolus water drinking, compression stockings, abdominal binders and physical counter-manoeuvres. Service evaluation in primary, secondary and tertiary care will define existing practice, and identify potential routes for translation. WP2: The scientific theory underpinning non-drug therapies. Therapies identified in WP1 will be evaluated in the clinical laboratory to determine the scientific theory for their use. People with OH aged >60 years, will attend for detailed, physiological neuro-cardiovascular assessment to observe the effects of each therapy. This will involve 3 separate assessments, lasting 60-90 minutes each (baseline evaluation, effects of single therapy and effects of combination therapy). A single therapy will be considered worthy of further evaluation if it reduces the drop in BP by 10 mmHg in over 30% of participants (defined by expert opinion and consensus). Combination therapy will be considered effective if it reduces BP drop in an additional 20% of individuals. WP3: Acceptability of non-drug therapies and strategies to improve adherence. In-depth, semi-structured interviews lasting up to 90 minutes with patients and with clinicians will identify acceptability of, and barriers to, non-drug therapies, using qualitative thematic analysis. Routes to improve adherence will be identified based on theoretical domains of behaviour change. A working group of patients, clinical academics and behaviour change experts will develop a strategy to promote uptake and adherence which will be immediately clinically relevant, and will inform WP4. WP4: Feasibility of a clinical trial. The design of a clinical trial will be refined through collaboration with patients and clinicians to review acceptability of recruitment, methodology, follow-up, dissemination and translation. In conjunction with the Clinical Trials Unit, potential sites for a multi-centre study will be contacted to gather feasibility data. Health economic questionnaires will be assessed for acceptability and relevance. At completion, a scientifically robust, acceptable and clinically relevant clinical trial protocol will be ready for submission to a funding body. Benefits Within 5 years, this study will summarise existing evidence and practice for clinicians, advance scientific understanding of how non-drug therapies work and inform clinicians which non-drug therapies are unacceptable. Furthermore, the working group from WP3b will develop an adherence strategy that will be immediately clinically relevant for 3.5 million older people using existing non-drug therapies. Within 5 years of completion, a clinical trial will be completed, resulting in high quality, clinically relevant evidence to improve the quality of life for millions of older people with OH. As the cost of non-drug therapies are low and the consequences of OH are expensive, it is anticipated that the results will have significant economic impact.

Lay abstract: Orthostatic hypotension (OH) occurs when blood pressure drops on standing, but effective treatments are lacking. OBJECTIVES: Develop a non-drug therapy to treat older people with OH. DESIGN: 1. Evaluate existing research and treatments. 2. Determine how non-drug therapies treat OH. 3. Design an appropriate therapy, and clinical trial to evaluate this therapy. OUTCOMES: 1. Summary of existing research. 2. Knowledge about how therapies work. 3. Strategies helping patients adhere to therapies. 4. Protocol to test the resulting therapy. BENEFITS: Short-term: Help 3.5 million older people adhere to existing non-drug therapies. Long-term: improve clinical care of older people with OH.

Research activity codes: 5.7 PHYSICAL;6.7 PHYSICAL
Health categories: CARDIOVASCULAR