Plain English Summary
Background and study aims
Meeting the needs of the growing number of older people with complex health and social problems remains a challenge to the NHS and social care. As people continue to live longer, it is important to find better ways to support their health and well-being so that they can stay active and independent for as long as possible. It is estimated that around 44% of older people have symptoms of mild frailty. Common difficulties that can be experienced include getting tired more easily, feeling weaker, a loss of appetite, low mood or finding it harder to go outdoors regularly. Having early support with these sorts of difficulties can help to maintain independence for longer. Health promotion is a way of helping people to have more control over their health so that they can improve it. Health promotion programmes aimed at older people have been introduced in the NHS in recent years, as they have the potential to make a real difference. In this study, a home-base health and well-being promotion programme has been designed in order to help promote healthy aging. The aim of this study is to find out whether this programme is feasible an acceptable way of delivering health and well-being promotion to older people in the community.
Who can participate?
Adults over 65, living at home with symptoms such as feeling like everything is more of a struggle, loss of energy or muscle strength.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in a personally tailored health and well-being promotion programme, delivered using a combination of home visits by a HomeHealth worker and telephone calls over a period of 6 months. Those in the second group continue to receive treatment as usual throughout the study. At the start of the study and after 3 and 6 months, participants in both groups will be asked to complete a number of questionnaires designed to assess their general health and mental well-being. At the end of the 6 month study, the possibility of conducting a larger trial is examined by reviewing the number of participants who have taken part in the study and how many participants completed the study.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University College London (UK)
When is the study starting and how long is it expected to run for?
November 2014 to March 2016
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
1. Ms Kalpa Kharicha (public)
k.kharicha@ucl.ac.uk
2. Dr Kate Walters (scientific)
Trial website
Contact information
Type
Public
Primary contact
Ms Kalpa Kharicha
ORCID ID
Contact details
Department of Primary Care and Population Sciences
Hampstead Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom
+44 20 7830 2392
k.kharicha@ucl.ac.uk
Type
Scientific
Additional contact
Dr Kate Walters
ORCID ID
http://orcid.org/0000-0003-2173-2430
Contact details
Dept. Primary Care & Population Health
University College London (UCL)
Royal Free Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
17444
Study information
Scientific title
Home based health promotion for vulnerable older people
Acronym
Study hypothesis
To develop and test feasibility/acceptability of a new home-based intervention to promote health and well-being of older people with early frailty.
For detailed study objectives and study protocol please see: http://www.nets.nihr.ac.uk/projects/hta/1219210
Ethics approval
NRES Committee London - Camden & Islington, 03/10/2014, ref: 14/LO/1698
Study design
Randomised; Interventional; Design type: Prevention, Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please contact Kalpa Kharicha (k.kharicha@ucl.ac.uk) to request a patient information sheet
Condition
Topic: Primary Care, Ageing; Subtopic: Ageing, Ageing; Disease: All Diseases, All Ageing
Intervention
General Practices will identify eligible patients and invite them to take part. Participants will be randomised to receive the intervention or treatment as usual. Intervention visits will be recorded and assessed for content/fidelity.
The intervention, called "HomeHealth", was developed in the first phase of the study, using a co-design process. It is an assets-based intervention, with the emphasis on maintaining capability to perform tasks that are important to the individual and participating in activities that the individual takes pleasure in. It is underpinned by behaviour change theory and employs techniques including goal-setting and breaking down tasks into manageable steps. Behaviour change aspects of the intervention will be based on the COM-B model, which is a behaviour system involving three essential conditions: Capability, Opportunity, and Motivation.
The content of the HomeHealth service will be tailored to the needs of the individual, and will include an assessment of four core areas known to impact on frailty: mobility (balance and muscle strength), diet and nutrition, social networks and mood. Other potential areas that may be included in the service (according to individual need) are: memory concerns, medication use, sensory impairment, pain, incontinence, needs of the individual as a carer, and social/practical factors (e.g. maintaining their home or managing finances).
The HomeHealth worker will offer an initial up to 6 appointments, with the option of a further 6 if required, over a maximum period of 6 months. The initial assessment visit will be face-to-face and subsequent appointments can be face-to-face or by telephone or skype as appropriate.
Those randomised to the control arm will receive treatment as usual. Both groups will receive a booklet of local services and healthy ageing advice at 6 months follow-up. The consort diagram below outlines the follow-up for both arms. The duration of follow-up is 6 months (i.e. immediately post the 6 months intervention period only) as this is a feasibility randomised controlled trial.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Feasibility is determined by successful recruitment and retention into the study, measured at the end of the trial period
Secondary outcome measures
1. Quality of life outcomes are measured using the EQ-5D questionnaire at baseline and 6 months
2. Activity levels are measured using the International Physical Activity Questionnaire – Extended (IPAQ-E) at baseline and 6 months
3. Alcohol use is measured using the Alcohol Use Disorders Identification Test (AUDIT-C) at baseline and 6 months
4. Capability adjusted life years are measured using ICECAP-O at baseline and 6 months
5. Mental well-being is measured using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at baseline and 6 months
6. Psychological morbidity is measured using the 12-item General Health Questionnaire (GHQ-12) at baseline and 6 months
7. Grip strength is measured using a dynamometer at baseline and 6 months
8. Anthropomorphic factors (weight, height and BMI) are measured at baseline and 6 months
9. Mobility is measured using gait speed at baseline and 6 months
10. Smoking is measured using participant interviews at baseline and 6 months
11. Cognitive functioning is measured using the Montreal Cognitive Assessment (MoCA) at baseline and 6 months
12. Patient demographics are self-reported at baseline
13. Social and community services uptake is measured using an adapted Client Service Resource Inventory at baseline, 3 and 6 months
14. Functioning is measured using the Modified Barthel index at baseline and 6 months
15. Frailty is measured using the electronic frailty index (from medical records, where possible) at baseline and after 6 months follow-up
16. Prescribed medication is determined from medical records at baseline and after 6 months follow-up
Overall trial start date
01/11/2014
Overall trial end date
28/02/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 65 or over
2. Registered with one of participating General Practices
3. Score as ‘pre-frail’ (0.2 - 0.35 on the Frailty Index of cumulative deficits 9)
4. Community-dwelling (including people living in extra care housing)
5. Life expectancy greater than 6 months
6. Capacity to consent to participate in this research (including those with dementia or communication difficulties who retain capacity to consent)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 100; UK Sample Size: 100; Description: For the qualitative study, we will interview 10 older people with early frailty, and conduct focus groups with up to 40 carers, home care workers, and community health professionals. To test feasibility we will identify 12-13 eligible older people per GP practice, in 4 practices in London and Hertfordshire (total sample target: 50 participants)
Participant exclusion criteria
1. Those living in care homes
2. On GP palliative care register
3. Those who lack capacity to consent (e.g. advanced dementia); those already case managed (e.g. by community matrons, some reablement schemes)
Recruitment start date
15/12/2014
Recruitment end date
30/04/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London
Department of Primary Care and Population Sciences
Hampstead Campus
London
NW3 2PF
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
1. Findings will be disseminated widely to policy makers, practitioners, researchers and the public. Policy makers will include NHS England & Clinical Commissioning Groups (CCGs), Public Health England and Health and Well-being Boards, and those developing NICE Guidance.
2. Findings, and the methodological lessons learned, will also be disseminated through publication in journals, to reach policy makers, and conference presentations in ageing, health services and primary and social care.
These results will also be publicised through social media to achieve a wide reach.
Intention to publish date
31/12/2017
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29214975