Condition category
Signs and Symptoms
Date applied
03/11/2014
Date assigned
19/02/2015
Last edited
19/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The number of older people living in care homes in the UK is increasing. These residents have chronic, complex and multiple health needs. They are often frail, disabled, have mental health issues and cognitive impairment. This means that they are often highly dependent on others and need skilled care and support. Participation in meaningful physical, social and mental activity is important to their health and quality of life and this is highlighted in UK national guidance. However, this is not always provided in care homes for a number of reasons including organisational culture, physical environment, staff lacking knowledge, expertise and confidence and also individual resident barriers. Residents therefore spend long periods of time inactive and sedentary which worsens their existing health problems. Emerging research suggests that effective person-centred programmes that create stimulating, meaningful physical and mental activity and social interaction requires a “whole–systems” approach that centres on the needs of the individual whilst at the same time addressing organisational and environmental barriers, and empowering and educating well trained staff. Here, we want to test whether a personalised activity programme with accompanying environmental and organisational changes – Active Residents in Care Homes Programme (ARCH) – improves the physical activity, health and quality of life of residents. The study objectives are to deliver the ARCH programme in three residential care homes in south London, evaluate the effect of the programme on participants, explore the experiences of those involved and measure the costs of the programme.

Who can participate?
Residential care homes for older people located in south London. Participants will be residents living in one of the participating residential care homes who are aged over 65 years old, staff working at the participating care homes, and family members of residents living at participating care homes.

What does the study involve?
A specialist therapy team made up of an occupational therapist, physiotherapist and rehabilitation assistant implement the ARCH programme in each participating care home over a 12 month period. ARCH is programme designed to increase opportunities for residents in care homes to engage in meaningful activities. It takes a whole systems approach addressing environmental, organisational and individual barriers to activity and uses meaningful activity as a way of encouraging physical activity. Researchers from Kingston University and St George’s University of London assess the difference the programme makes to older residents by recruiting 10-15 residents to take part in a number of outcome measures at three different time points: before the programme is delivered and then four and 12 months after the programme starts at the care homes. The outcome measures will collect information about the health status and quality of life of residents. This information is being collected at different time periods so the researchers can explore change over time. Residents will also be invited to take part in semi-structured interviews at these three time periods to explore their opinions and experiences: firstly, of current care provision and opportunities for activity in the care home, and secondly, of their experiences and perceptions of the ARCH programme. Care home staff and residents’ family members will also be recruited to take part in semi-structured interviews at the three time periods (before the programme is delivered and then four and 12 months after the programme starts) to explore their experiences and perceptions of the programme. Information about the costs of implementing the programme will also be collected and analysed.

What are the possible benefits and risks of participating?
It is extremely unlikely that residents will come to any harm by taking part in this study. However, as this study is about improving opportunities for activity there is a small risk that by engaging in such activities residents could incur injuries (e.g. via falling, or straining) or develop/worsen physical health problems. The use of trained and experienced therapists and the person-centred approach of the programme, which ensures activities are tailored to the needs and abilities of residents, will ensure this risk is minimal. It is also possible that residents could become distressed or tired when taking part in the research activities, however the ethical conduct of the research will minimise this risk. Participation in the study for staff will involve the incorporation of new working practices, and it is possible that staff members may find this burdensome, particularly in relation to the demands on their time. The presence of a dedicated and skilled therapy team working alongside them in addition to a bespoke programme of training, the collaborative nature of the implementation and the relatively long time period (12 months) for implementation will minimise this risk. There are no obvious risks to staff or family members in taking part in the semi-structured interviews. However it is possible that some staff or family members may find it upsetting to discuss issues related to the health and wellbeing of older people living in the care home. Researchers will show sensitivity and signpost participants to appropriate support if this occurs. If the programme is effective and experiences are positive then older residents will potentially benefit from improved health, quality of life and the reduction of the detrimental effects of inactivity. Family members and caregivers will potentially have greater opportunities for active involvement in the care of loved ones and see improvements in the care and wellbeing of their loved ones. Care home staff will develop the confidence and skills to become active carers, providing more appropriate care that optimises resident’s wellbeing, independence and dignity, increasing personal job satisfaction, improved self-worth and potentially reducing their workload. In addition, the benefits of taking part in semi-structured interviews for residents, staff and family members include: having the opportunity to share their views and experiences of the ARCH programme; being able to play an active role in shaping the future of the programme; and helping to ensure that the care and activities provided at the care home meet the needs of residents.

Where is the study run from?
Kingston University and St George’s University of London (UK).

When is the study starting and how long is it expected to run for?
June 2014 – May 2017.

Who is funding the study?
The Chartered Society of Physiotherapy’s Charitable Trust (UK)

Who is the main contact?
Sian Koskela
sian.koskela@sgul.kingston.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Michael Hurley

ORCID ID

Contact details

School of Rehabilitation Sciences
Faculty of Health
Social Care and Education
St Georges University of London and Kingston University
2nd Floor Grosvenor Wing
Cranmer Terrace
London
SW17 0RE
United Kingdom
-
Michael.Hurley@sgul.kingston.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14.0142

Study information

Scientific title

Assessing the feasibility, acceptability and efficacy of a personalised activity programme with accompanying environmental and organisational changes for older people in residential care homes

Acronym

ARCH Study

Study hypothesis

The implementation of a personalised activity programme with accompanying environmental and organisational changes – Active Residents in Care Homes Programme (ARCH) – will improve the activity levels, health and quality of life of residents.

Ethics approval

NRES Committee London - South East, 12/09/14, Ref. 14/LO/1329

Study design

This is a feasibility study estimating the parameters needed to inform the design of a large randomised controlled trial.

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

Engagement in activity, quality of life and quality of care for older people in residential care homes in the UK.

Intervention

ARCH is programme designed to increase opportunities for residents in care homes to engage in meaningful activities. It takes a whole systems approach addressing environmental, organisational and individual barriers to activity and uses meaningful activity as a way of encouraging physical activity. It draws from evidence based practice and best practice guides for working with people with dementia, and is informed by theoretical models used widely in occupational therapy such as the model of human occupation and the person-environment-occupation model. The programme is implemented in the care home over a 12 month period as a partnership between a specialist therapy team made up of an occupational therapist, physiotherapist and rehabilitation assistant, and the care home.

The therapists will start the implementation of the programme by completing a macro assessment of the care home. To complete this assessment they will embed themselves in the care home through a series of observations and interviews. This process will enable them to gain an understanding of the day to day running of the home and to identify the facilitators and barriers to levels of meaningful activity for residents. The therapists’ findings will be shared with care home management and other relevant stakeholders and a basic implementation plan will be negotiated and agreed. This plan will focus on the following areas - resident wellbeing and meaningful activity; organisational structure; staff approach and social environment; and physical environment – with the overall aim of increasing opportunities for residents to engage in activity.

A bespoke training programme, based on the findings from the macro assessment will be developed for care home staff. This will consist of formal training modules and on-floor learning with the therapists. Alongside the training programme therapists will complete more in depth assessments of residents which will feed into the training activities of staff by acting as ‘live cases’ for staff to practically carry out what they are learning and relate it to the people they work with. As the training continues the therapists will used their understanding of these residents and work with staff to formulate and start to implement individual activity plans. After four months the occupational therapist and physiotherapist will withdraw from the home and the rehabilitation assistant will assume a primary role in supporting staff to continue with the activities of the programme. The rehabilitation assistant will fulfil this supportive function, whilst also maintaining a link between the staff and the therapists for a further 8 months. After this period it is anticipated that the programme will have become fully embedded in the home and that staff will have the confidence and competence to carry on utilising the framework and ethos of the ARCH programme.

Intervention type

Phase

Not Applicable

Drug names

Primary outcome measures

1. Dementia Care Mapping (Brooker, 2005): an observational technique developed by the Bradford Dementia Group which evaluates quality of care and quality of life from the perspective of the person with dementia. It also captures information about levels of activity.
2. Pool Activity Level Checklist (Pool, 2012): measures the ability of residents to engage in activity and is completed by carers/care home staff.
3. Assessment of Physical Activity in Frail Older People (Hauer, Lord, Lindemann, Lamb, & Aminian, 2011): an interview administered subjective assessment of physical activity, mobility and function, designed and validated specifically for frail older people with and without mild to moderate cognitive impairment.
4. EQ-5D-5L (Dolan, Gudex, Kind, & Williams, 1995): measures of health related quality of life and can be administered as a self completion questionnaire or via interview. Information collected by this measure is used to inform the evaluation of cost-effectiveness also.
5. Review of care home records in order to document: any adverse events arising from the programme e.g. falls or injuries;residents’ health service utilisation e.g. number of ambulance service call outs, GP appointments and hospital admissions,any changes in medication usage.

Secondary outcome measures

Semi-structured interviews with residents, staff and family members to explore their experiences, opinions and perceptions of the programme.

Overall trial start date

01/06/2014

Overall trial end date

31/05/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Residential care homes:
1. Supports individuals aged over 65
2. Has a dementia specific unit or includes persons with dementia
3. Located a minimum of 1.5 hrs travel time from the St John’s Therapy Centre, Clapham Junction
Care home residents:
1. Be living in a residential care home taking part in the study
2. Aged over 65
3. Willing to participate in the study
Care home staff:
1. Should have been employed at the care home for a minimum of three months at the time of recruitment in a careworker role
2. Willing to participate
Family members:
1. Relative of a resident participating in the study and willing to participate.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

114 participants.

Participant exclusion criteria

Care homes:
1. Has onsite nursing, physiotherapy or occupational therapy provision
2. Is undergoing any enforcement actions by the Care Quality Commission (CQC) as detailed in their most recent inspection report
3. Is under current investigation by the CQC or embargo from social services
4. Is involved in other research activities
Care home residents:
1. Are unable to be cared for out of bed
2. Unable to maintain a seated upright position
3. Are unable to follow simple commands due to severe cognitive impairment
Care home staff:
1. Staff members not engaged in care worker role

Recruitment start date

01/06/2014

Recruitment end date

31/05/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St George's University of London and Kingston University
London
SW17 0RE
United Kingdom

Sponsor information

Organisation

St George's, University of London and St George's Healthcare NHS Trust (UK)

Sponsor details

c/o Ms Lucy Parker
Clinical Research Governance Manager
Joint Research Enterprise Office
St George's
University of London and St George's Healthcare NHS Trust
Cranmer Terrace
London
SW17 ORE
United Kingdom
-
l.parker@sgul.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Chartered Society of Physiotherapy's Charitable Trust. Funder reference: PFR(13)PA18.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes