Title page
Home-based health promotion for older people with mild frailty (HomeHealth): intervention development and feasibility Randomised Controlled Trial
Authors and affiliations
Kate Walters1*
Rachael Frost1
Kalpa Kharicha1
Christina Avgerinou1
Benjamin Gardner2
Federico Ricciardi3
Rachael Hunter1
Ann Liljas1
Jill Manthorpe4
Vari Drennan5
John Wood1
Claire Goodman6
Ana Jovicic1
Steve Iliffe1
1Department of Primary Care and Population Health, University College London, London, UK.
2Department of Psychology, King’s College London, London, UK
3Department of Statistical Science, University College London, London, UK
4Social Care Workforce Research Unit, King’s College London, UK
5Centre for Health and Social Care Research, Kingston University & St George’s, University of London, London, UK
6Centre for Research in Primary and Community Care, University of Hertfordshire, Hertfordshire, UK
Competing interests: None declared
*Corresponding author: Dr Kate Walters, Director Centre for Ageing Population Studies
University College London
Royal Free Campus, Rowland Hill St
London, NW3 2PF
Keywords: Frail Elderly, Health Services for the Aged, Aged, Health Promotion, Preventive Health Services, Clinical Trial, Review, Qualitative Research
Word count report: 44,714 words
Abstract
Background: Mild or pre-frailty is common yet 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:
To develop an evidence and theory-based home-based health promotion intervention for older people with mild frailty.
To test feasibility, costs and acceptability of the intervention, and of a full-scale clinical and cost-effectiveness Randomised Controlled Trial (RCT).
Design: Evidence reviews, qualitative studies, intervention development, 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 (inception-2015) and policy review identified effective components for our intervention.
We collected data on health priorities and potential intervention components from semi-structured interviews and focus groups with older people (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 multi-disciplinary 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 wellbeing goals, supported througheducation, 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, United Kingdom.
Participants: 51 community-dwelling adults aged 65years+ with mild frailty
Main outcome measures:Feasibility: recruitment, retention, acceptability, intervention costs
Clinical and health economic outcome data at 6 months included: Functioning, frailty status, well-being, psychological distress, quality of life, capability, NHS and societal service utilisation/costs.
Results: We successfully recruited to target, with good 6 months 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/patient). 96% of participants identified at least one goal, mostly exercise-related (73%). We found significantly better functioning (Barthel Index; +1.68, p=0.004), grip strength (+6.48kg, p=0.02), reduced psychological distress (GHQ-12; -3.92, p=0.01) and increased capability-adjusted life years (+0.017; 95% CI 0.001 to 0.031) at 6 months compared to TAU, with no differences in other outcomes. NHS and carer-support costs were variable, but overall lower in the intervention 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 multi-domain 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 multi-component 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 randomised RCT is feasible.
Next steps: A large, definitive RCT of the HomeHealth service is warranted.
Study registration: PROSPERO: CRD42014010370; Trials ISRCTN11986672
Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. XX, No. XX. See the NIHR Journals Library website for further project information.
(Abstract word count: 467 words not including funding statement, 503 words including funding statement)
Contents
Abstract
Contents
List of tables
List of figures
List of boxes
Plain English Summary
Scientific Summary
Chapter 1: Background
1.1Introduction
1.2Objectives
1.3Ethics and governance
1.4Public involvement and engagement
Chapter 2: Intervention development – Identifying effective content for a new service
2.1Identifying components of effective interventions – systematic review of interventions targeted at community-dwelling older people with mild or pre-frailty
2.1.1Objectives
2.1.2Methods
2.1.3Results
2.1.4Synthesis
2.1.5Key Findings
2.1.6Implications for intervention development
2.2Using behavioural science to develop a new complex intervention: An exploratory review of the content of home-based behaviour change for older people with frailty or at risk of frailty
2.2.1Intervention functions
2.2.2Behaviour change techniques
2.2.3Aims
2.2.4Methods
2.2.5Results
2.2.6Behavioural targets
2.2.7Intervention functions
2.2.8Behaviour change techniques
2.2.9Key findings
2.2.10Implications for intervention development
2.3What can we learn from effective single-domain health promotion interventions with frailer older populations? ‘State of the art’ scoping review of systematic reviews.
2.3.1Objectives
2.3.2Methods
2.3.3Key findings of relevance to design of our new intervention
2.3.4Implications from the ‘state of the art’ review:
2.4Policy context: How does a new health promotion service for people with mild frailty fit with current policy and practice?
2.4.1Background
2.4.2Method
2.4.3Findings
2.4.4Discussion and conclusion
2.5Evidence reviews: Discussion
Chapter 3: Intervention development with older people, carers and community health and social care professionals
3.1Exploring user perspectives on the aims, content and delivery of a new home-based health promotion service for older people with mild frailty
3.2WISH Study
3.2.1Methods and sample
3.2.2Key findings of importance to service development for mild frailty
3.2.3Implications for service development:
3.3Tailoring a new home-based health promotion service for older people with mild frailty: Qualitative study of older people, carers and health and social care professionals
3.3.1Aims
3.3.2Methods
3.3.3Results
3.3.4Summary of key findings
3.4Development of the HomeHealth service
3.5Theoretical framework
3.6Synthesis of key points from evidence reviews and qualitative work
3.6.1Key points from evidence reviews:
3.6.2Key points from qualitative studies:
3.6.3Summary of core intervention components integrating theory with evidence from literature reviews and qualitative studies:
3.7Service development
3.7.1Consultation with key stakeholders
3.7.2Service development panels
3.7.3Participants and settings
3.7.4Service development panel meetings
3.7.5Outcomes
3.7.6Summary
3.8HomeHealth: intervention description
3.8.1Service content
3.8.2Behaviour change content
3.8.3Delivery
3.8.4HomeHealth Project Workers
3.8.5Training
3.8.6Supervision
3.9Modifications to the trial protocol
3.10Discussion
Chapter 4 Phase II: Feasibility Randomised Controlled Trial: Methods
4.1Objectives
4.2Overview of trial design
4.3Trial registration
4.4Trial setting
4.5Study participants
4.5.1Inclusion criteria
4.5.2Exclusion criteria
4.6Interventions
4.7Measurements
4.7.1Feasibility and acceptability success criteria
4.7.2Clinical outcomes
4.7.3Frailty measurements
4.7.4Other outcomes
4.7.5Health economic outcomes
4.7.6Demographics
4.8Feasibility and acceptability of trial procedures
4.9Defining ‘treatment as usual’
4.10Harms
4.11Participant timeline
4.12Sample size calculation
4.13Methods for participant recruitment
4.14Randomisation
4.15Blinding
4.16Data entry
4.17Statistical methods
4.17.1Feasibility outcomes
4.17.2Outcome measures
4.18Health economic analysis
4.18.1Intervention costs
4.18.2Feasibility and acceptability of collecting relevant health economic data
4.18.3Service use
4.16.4 Quality- and capability-adjusted life years
4.16.5 Societal perspective
4.16.6 Budget impact analysis
4.19Safety
4.20Adherence
Chapter 5 Feasibility Randomised Controlled Trial (RCT): Results
5.1Participant flow
5.1.1Recruitment
5.1.2Retention
5.2Baseline data
5.2.1Participant characteristics
5.2.2Baseline functional, physical, psychological and lifestyle measures
5.2.3Baseline Fried Frailty Phenotype
5.2.4Caring responsibilities
5.3Clinical outcomes at 6 months
5.3.1Functional, physical, psychological and lifestyle outcomes
5.3.2Frailty status
5.3.3Caring responsibilities
5.3.4Supplementary analyses
5.4Health economic outcomes
5.4.1Intervention costs
5.4.2Quality and capability-adjusted life years
5.4.3Service use
5.4.4Societal perspective
5.4.5Budget impact analysis
5.5Feasibility and acceptability of trial processes
5.5.1Data collection
5.5.2Participants’ views on trial processes
5.6Defining ‘Treatment As Usual’
5.6.1Questionnaires with control arm
5.6.2Data from CSRI for control arm
5.7Adverse events
5.7.1Serious adverse events (SAEs)
5.7.2Adverse events
5.8Researcher blinding
5.9Discussion
Chapter 6 Process evaluation
6.1Objectives
6.2Methods
6.2.1Recruitment and retention data
6.2.2HomeHealth Service documentation
6.2.3Participant questionnaires
6.2.4Semi-structured interviews with participants
6.2.5Intervention fidelity: audio-recording of intervention appointments
6.3Results
6.3.1Recruitment and retention data
6.3.2Home Health Service documentation
6.3.3Fidelity of delivery: analysis of audio-recorded appointments
6.3.4Questionnaire data
6.3.5Semi-structured interview findings
6.4Discussion
Chapter 7 Discussion
7.1Summary of findings
7.2Implications for practice, service delivery and commissioning
7.3Implications for research
Acknowledgements
Contribution of authors:
Publications arising from this grant:
Published
Submitted (under review/revision):
Disclaimer:
References
List of tables
Table 1 Summary of characteristics and findings from studies included in the review
Table 2 Characteristics of included observational studies
Table 3 Meta-analysis of outcomes within this review
Table 4 Behavioural content and evidence of effectiveness
Table 5 Summary of data collection methods for the qualitative study
Table 6 How can this content be delivered?
Table 7 TIDIER summary of the HomeHealth intervention
Table 8 Outcomes assessed at each time point
Table 9 Fried frailty criteria used in HomeHealth
Table 10 Participant descriptive characteristics
Table 11 Participants' social and economic characteristics
Table 12 Baseline clinical participant data
Table 13 Fried frailty phenotype at baseline
Table 14 Caring responsibilities at baseline in those reporting caring
Table 15 Clinical outcome data at 6 months, presented as raw summary data and effect sizes adjusted for key variables
Table 16 Fried Frailty Phenotype at 6 months
Table 17 Caring responsibilities at 6 months in those reporting caring
Table 18 Intervention costs
Table 19 QALYs and CALYs at 6 months
Table 20 Costs of service use per participant
Table 21 Benefits received
Table 22 Impact on use of services for care and support
Table 23 Costs of care and support services
Table 24 Demographic characteristics of older people interviewed
List of figures
Figure 1 PRISMA flow diagram of studies included in the review
Figure 2 PRISMA flow diagram of studies included in the state-of-the-artreview
Figure 3 Logic model of the HomeHealth intervention6
Figure 4 Participant flow throughout the feasibility study
Figure 5 Flow diagram of participants through the trial
Figure 6 Monthly recruitment for the HomeHealth trial
Figure 7 Distribution of topics covered by the HomeHealth service (over total number of outcome goals/topics covered)
List of boxes
Box 1 Commonly used definitions of mild frailty
Box 2 The government mandated health prevention and health improvement outcomes in relation to older people for public health, the NHS and social care
Box 3 Service delivery mechanisms for prevention relevant to older adults
List of Supplementary Material
Supplementary Material 1: Commissioning Brief
Supplementary Material 2: Review search terms
Supplementary Material 3: BCT included studies table
Supplementary Material 4: Topic guides for qualitative intervention development
Supplementary Material 5: Process evaluation questionnaires
Supplementary Material 6: HomeHealth baseline service use Case Report Form
Supplementary Material 7: Health economic service use tables
Supplementary Material 8: Process evaluation topic guide for older people
Supplementary Material 9: Fidelity checklists
List of abbreviations
ADLactivities of daily living
AUDIT-CAlcohol Use Disorders Identification Test – Consumption
AEadverse event
BCTbehaviour change technique
BGbehavioural goal
BMIbody mass index
CALYCapability-adjusted life year
CONSORTConsolidated Standards of Reporting Trials
CSRIClient Services Receipt Inventory
CTU clinical trials unit
EFIelectronic frailty index
EQ-5D-5LEuroQol EQ-5D 5 level
ICECAP-OICEpop CAPability measure for Older people
IADLinstrumental activities of daily living
IMDIndex of multiple deprivation
IPAQ-EInternational Physical Activity Questionnaire for the Elderly
GHQ-1212-item General Health Questionnaire
GPgeneral practitioner
MCImild cognitive impairment
MMSEMini-Mental State Examination
MoCAMontreal Cognitive Assessment
MRCMedical Research Council
NHSNational Health Service
PRISMAPreferred Reporting Items for Systematic Reviews and Meta-Analyses
QALYquality-adjusted life year
RCT randomised controlled trial
SAEserious adverse event
SDstandard deviation
SMDstandardised mean difference
TIDIERtemplate for intervention description and replication
WEMWBSWarwick-Edinburgh Mental Wellbeing Scale
WISHWellbeing Interventions for Social and Health needs in older people study
Plain English Summary
With age, people often develop an increasing number of health conditions that affect how they feel and their ability to remain independent. Some may struggle with decreased energy levels, low appetite, lower muscle strength and difficulty with household tasks like shopping and cooking. However, few health services currently exist to help. This study aimed to design a new service to promote health for older people experiencing such symptoms, and test whether the service was acceptable.
We reviewed existing research to identify content areas for the new service including physical activity, socialising, poor nutrition and low mood. Forty-four older people, 12 carers and 27 health/social care professionals from a variety of backgrounds told us that maintaining independence was the paramount issue for older people, and that the service should address keeping mobile and staying socially active, in addition to the specific issues of each individual. They recommended the service be provided by trained, empathetic non-specialist support workers.
Hence, we designed a new service, together with older people, health/social care professionals, the voluntary sector, policy-makers and experts. The service focussed on maximising what older people already have and enjoy doing, supporting them to maintain this and address symptoms such as tiredness/weakness. It consisted of an average of five home-based appointments over six months.
We piloted our new service with 51 older people from four General Practices. Half were randomly allocated to receive the service and after six months their outcomes were compared to people who had not received the service. We assessed whether it was feasible to run a larger study to test the effectiveness and cost-effectiveness of the new service. Findings suggested the service was acceptable to people receiving it, showed promise in helping people stay independent and feel better, was of modest cost and merited a larger study (trial).
(Plain English Summary word count: 300 words)
Scientific Summary
Background
Frailty is common in older adults and is associated with an increased risk of adverse outcomes, including hospitalisation, functional decline, poor quality of life, increasing dependency and avoidable death. It has a major impact on health and social care costs, which will increase over the coming decades as the population ages. However, frailty is a transitional process and there exists an intermediate state of pre-, early or mild frailty, in which people are neither robust nor frail but experience some symptoms of frailty (e.g. feeling slowed up or weaker) but are not yet dependent on others for activities of daily living. Estimates suggest that up to around 40% of older adults may be mildly or pre-frail and that over time they may transition to worsening frailty, stay the same or improve.
Mild frailty therefore represents an important opportunity to promote health and prevent frailty and future decline. Most mild or pre-frail individuals do not present with overt symptoms and are easier targeted at home. Health promotion interventions in frail and high risk populations have had mixed success, whilst reviews suggest health promotion benefits may be greater in older adults who are younger and at lower risk of mortality. However, evidence as to the most effective ways to promote health in this population and how they may be delivered in a feasible and cost-effective way at scale is lacking. We aimed to develop a new home-based service for promoting health, functioning and well-being in mild frailty; and assess its feasibility, acceptability and costs in a feasibility randomised controlled trial.
Objectives
Our objectives were to:
- Systematically review and synthesise existing evidence for home-based health promotion interventions for older people with mild frailty.
- Explore how health and social care policies address health promotion with older people with mild frailty.
- Explore key components for a new home-based health promotion intervention in interviews/focus groups with older people, carers, home care workers and community health professionals.
- Co-produce a new health promotion intervention for older people with mild frailty with older people, carers, health/care professionals and other experts.
- Test acceptability and feasibility for delivery in the NHS, and of recruitment, retention, outcomes and study procedures for a full Randomised Controlled Trial (RCT).
- Determine the intervention costs, test the feasibility of collecting health economic data to calculate costs and effects and determine the feasibility of calculating cost-effectiveness for a full RCT from health and societal perspectives.
- Conduct a mixed methods process evaluation exploring the context, potential mechanisms and pathways to impact of the intervention.
Intervention development
Evidence reviews
Methods
We conducted a series of evidence reviews to inform intervention development:
- Systematic review of 14 databases/registries (1990-2016) for RCTs, observational and qualitative studies of home/community based interventions for older people with mild or pre-frailty.
- Systematic review of 15 databases/registries (1980-2014) for RCTs of home-based,multi-domain health promotion interventions for older people with frailty/at risk of frailty, to identifyBehaviour Change Techniques employed within interventions and explore potential contribution to intervention effects.
- A state-of-the-art review of systematic reviews from 3 databases (inception-2015) of single-domain interventions to promote health in fields of exercise and mobility, falls prevention, nutrition and diet, social engagement, mental health and memory in frailer or ‘at-risk’ older adults.
- Policy scoping review and documentary analysis of state laws, national and local policy on frailty prevention, using iterative web-searches of key documents, and a purposive sample of local government and health commissioning websites.
Results