Home-based health promotion for older people with mild frailty: the HomeHealth intervention development and feasibility RCT

There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

Abstract

Background

Mild frailty or pre-frailty is common and yet is potentially reversible. Preventing progression to worsening frailty may benefit individuals and lower health/social care costs. However, we know little about effective approaches to preventing frailty progression.

Objectives

(1) To develop an evidence- and theory-based home-based health promotion intervention for older people with mild frailty. (2) To assess feasibility, costs and acceptability of (i) the intervention and (ii) a full-scale clinical effectiveness and cost-effectiveness randomised controlled trial (RCT).

Design

Evidence reviews, qualitative studies, intervention development and a feasibility RCT with process evaluation.

Intervention development

Two systematic reviews (including systematic searches of 14 databases and registries, 1990–2016 and 1980–2014), a state-of-the-art review (from inception to 2015) and policy review identified effective components for our intervention. We collected data on health priorities and potential intervention components from semistructured interviews and focus groups with older people (aged 65–94 years) ( n = 44), carers ( n = 12) and health/social care professionals ( n = 27). These data, and our evidence reviews, fed into development of the ‘HomeHealth’ intervention in collaboration with older people and multidisciplinary stakeholders. ‘HomeHealth’ comprised 3–6 sessions with a support worker trained in behaviour change techniques, communication skills, exercise, nutrition and mood. Participants addressed self-directed independence and well-being goals, supported through education, skills training, enabling individuals to overcome barriers, providing feedback, maximising motivation and promoting habit formation.

Feasibility RCT

Single-blind RCT, individually randomised to ‘HomeHealth’ or treatment as usual (TAU).

Setting

Community settings in London and Hertfordshire, UK.

Participants

A total of 51 community-dwelling adults aged ≥ 65 years with mild frailty.

Main outcome measures

Feasibility – recruitment, retention, acceptability and intervention costs. Clinical and health economic outcome data at 6 months included functioning, frailty status, well-being, psychological distress, quality of life, capability and NHS and societal service utilisation/costs.

Results

We successfully recruited to target, with good 6-month retention (94%). Trial procedures were acceptable with minimal missing data. Individual randomisation was feasible. The intervention was acceptable, with good fidelity and modest delivery costs (£307 per patient). A total of 96% of participants identified at least one goal, which were mostly exercise related (73%). We found significantly better functioning (Barthel Index +1.68; p = 0.004), better grip strength (+6.48 kg; p = 0.02), reduced psychological distress (12-item General Health Questionnaire –3.92; p = 0.01) and increased capability-adjusted life-years [+0.017; 95% confidence interval (CI) 0.001 to 0.031] at 6 months in the intervention arm than the TAU arm, with no differences in other outcomes. NHS and carer support costs were variable but, overall, were lower in the intervention arm than the TAU arm. The main limitation was difficulty maintaining outcome assessor blinding.

Conclusions

Evidence is lacking to inform frailty prevention service design, with no large-scale trials of multidomain interventions. From stakeholder/public perspectives, new frailty prevention services should be personalised and encompass multiple domains, particularly socialising and mobility, and can be delivered by trained non-specialists. Our multicomponent health promotion intervention was acceptable and delivered at modest cost. Our small study shows promise for improving clinical outcomes, including functioning and independence. A full-scale individually RCT is feasible.

Future work

A large, definitive RCT of the HomeHealth service is warranted.

Study registration

This study is registered as PROSPERO CRD42014010370 and Current Controlled Trials ISRCTN11986672.

Funding

This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 73. See the NIHR Journals Library website for further project information.

Related collections

Most cited references 95

Record: found
Abstract: found
Article: found

Is Open Access

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

Sandra M. Eldridge, Claire L Chan, Michael J Campbell … (2017)

The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply. The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist. The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number. This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials. Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites. Electronic supplementary material The online version of this article (doi:10.1186/s40814-016-0105-8) contains supplementary material, which is available to authorized users.

0 comments Cited 318 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: found

Is Open Access

Evaluating and establishing national norms for mental wellbeing using the short Warwick–Edinburgh Mental Well-being Scale (SWEMWBS): findings from the Health Survey for England

Linda Ng Fat, Shaun Scholes, Sadie Boniface … (2016)

Purpose The Warwick–Edinburgh Mental Well-being Scale (WEMWBS), 14 positively worded statements, is a validated instrument to measure mental wellbeing on a population level. Less is known about the population distribution of the shorter seven-item version (SWEMWBS) or its performance as an instrument to measure wellbeing. Methods Using the Health Survey for England 2010–2013 (n = 27,169 adults aged 16+, nationally representative of the population), age- and sex-specific norms were estimated using means and percentiles. Criterion validity was examined using: (1) Spearman correlations (ρ) for SWEMWBS with General Health Questionnaire (GHQ-12), happiness index, EQ-VAS (2) a multinomial logit model with SWEMWBS (low, medium and high wellbeing) as the outcome and demographic, social and health behaviours as explanatory variables. Relative validity was examined by comparing SWEMWBS with WEMWBS using: (1) Spearman correlations (continuous data), and (2) the weighted kappa statistic (categorical), within population subgroups. Results Mean (median) SWEMWBS was 23.7 (23.2) for men and 23.2 (23.2) for women (p = 0.100). Spearman correlations were moderately sized for the happiness index (ρ = 0.53, P < 0.001), GHQ-12 (ρ = −0.52, p < 0.001) and EQ-VAS (ρ = 0.40, p < 0.001). Participants consuming <1 portion of fruit and vegetables a day versus ≥5 (odds ratio = 1.43 95% Confidence Interval = (1.22–1.66)) and current smokers versus non-smokers (1.28 (1.15–1.41)) were more likely to have low vs medium wellbeing. Participants who binge drank versus non-drinkers were less likely to have high versus medium wellbeing (0.81 (0.71–0.92)). Spearman correlations between SWEMWBS and WEMWBS were above 0.95; weighted kappa statistics showed almost perfect agreement (0.79–0.85). Conclusion SWEMWBS distinguishes mental wellbeing between subgroups, similarly to WEMWBS, but is less sensitive to gender differences. Electronic supplementary material The online version of this article (doi:10.1007/s11136-016-1454-8) contains supplementary material, which is available to authorized users.

0 comments Cited 158 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: not found

Normal walking speed: a descriptive meta-analysis.

Richard Bohannon, A Williams Andrews (2011)

Walking speed has implications for community functioning and is predictive of important outcomes. Determining whether an individual's walking speed is limited requires normal values for comparison. To use meta-analysis to describe normal gait speed for healthy individuals within age and gender strata. PubMed, the Cumulative Index of Nursing and Allied Health (CINAHL), Scopus, Science Citation Index and articles identified by hand searches. Inclusion required that the gait speed of apparently healthy adults was documented as they walked at a normal pace over a course of 3 to 30 m. Summary data were excluded unless obtained from at least 10 participants within a gender and decade stratum. The two authors independently reviewed articles and extracted data. Accuracy was confirmed by the other author. Data were grouped within gender and decade strata. A meta-analysis macro was used to consolidate data by strata and to determine homogeneity. Forty-one articles contributed data to the analysis. Combined, they provided data from 23111 subjects. The gait speed was homogeneous within strata and ranged from a mean of 143.4 cm/second for men aged 40 to 49 years to a mean of 94.3 cm/second for women aged 80 to 99 years. The data presented herein may not be useful as a standard of normal if gait is measured over short distances from the command 'go' or if a turn is involved. The consolidation of data from multiple studies reported in this meta-analysis provides normative data that can serve as a standard against which individuals can be compared. Doing so will aid the interpretation of their performance. Copyright © 2011 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.