Is it feasible to conduct a study to investigate whether the Care to Move (CTM) programme can encourage increased physical activity in older adults living in the community who are receiving low-level home care?
| ISRCTN | ISRCTN72605421 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72605421 |
| Secondary identifying numbers | HRB APA-2017-013 |
- Submission date
- 18/12/2019
- Registration date
- 08/01/2020
- Last edited
- 12/09/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
Older people who live alone can become anxious about falling. If they limit their standing and walking and spend a lot of time sitting or in bed, this reduces their strength and balance so that they are actually more likely to fall. Physical activity programmes have been shown to improve older adults’ health and well-being and also to reduce falls, enabling the older adult to live independently and maintain their functional status. However, there is a lack of high-quality research around physical activity in the person’s own home when they are starting to become frail and are receiving home care services. This small-scale study will investigate whether it is possible for trained home care workers to encourage their clients to to move more during home care and everyday living. If it is possible, a larger study will be conducted to measure how effective this approach is.
Who can participate?
Frail older adults (aged over 60 years) who are living at home and are receiving home care
What does the study involve?
The study will look at the feasibility of introducing the Care to Move (CTM) programme, and more importantly - how much older people like it. CTM was developed by Later Life Training (UK). CTM provides a series of consistent 'movement prompts' to include into movements of daily living and offers a series of key messages for care staff to communicate during all interactions about sitting less and moving more. This study will collect people’s experiences and opinions of the programme. The researchers will also look at how CTM could be delivered to older people at home, and what it costs, since this is important information for those who plan services. All participants will receive the CTM programme.
What are the possible benefits and risks of participating?
The benefits of physical activity for all ages are widely known. CTM is expected to encourage participants to move more with a view to encouraging and empowering older people to make different decisions to better contribute to their health, well-being, confidence and independence. Therefore participants might benefit from improved health and reduced anxiety.
Where is the study run from?
The School of Physiotherapy at the Royal College of Surgeons in Ireland, in collaboration with the Health Service Executive (Ireland), Healthcare Organisation (CHO) 9 (Ireland), and North Dublin Homecare (Ireland)
When is the study starting and how long is it expected to run for?
April 2019 to August 2021
Who is funding the study?
Health Research Board (Ireland)
Who is the main contact?
1. Professor Frances Horgan, fhorgan@rcsi.ie
2. Dr Austin Warters, austin.warters@hse.ie
Contact information
Scientific
School of Physiotherapy
Royal College of Surgeons in Ireland
123 St Stephen's Green
Dublin
2
Ireland
 ORCID ID |
0000-0002-8773-9953 |
|---|---|
| Phone | +353 1 402 2472 |
| fhorgan@rcsi.ie |
Study information
| Study design | Phase I non-randomized feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | ISRCTN72605421_PIS_v2_24May2018.pdf |
| Scientific title | Enhancing existing formal home care to improve and maintain functional status in older adults: A feasibility study on the implementation of the Care to Move (CTM) programme in an Irish healthcare setting |
| Study objectives | The aim of this study is to investigate the feasibility and acceptability of implementing the Care to Move (CTM) programme in older adults living in the community who are receiving low-level home care. |
| Ethics approval(s) | Approved 05/06/2018, Royal College of Surgeons in Ireland Research Ethics Committee (Office of Research and Innovation, 2nd Floor Ardilaun House Block B, 111 St Stephens Green, Dublin 2, Ireland; +353 1 4022205; recadmin@rcsi.ie), ref: 2018:1489 |
| Health condition(s) or problem(s) studied | Physical activity in frail older adults |
| Intervention | CTM was developed by Later Life Training (UK). CTM provides a series of consistent 'movement prompts' to use and embed into existing movements of daily living and offers a series of key messages for care staff to communicate during all interactions about sitting and moving more with a view to encouraging and empowering older people to make different decisions in the longer term to better contribute to their health, well-being, confidence and independence. CTM is not a structured exercise programme but is specifically designed to give home care workers and volunteers confidence to have empowering and motivating interactions with clients, patients and service uses across any setting or service working with older people. In this study, home care workers will be trained as CTM Motivators and will complete a 2-day CTM course. The CTM study participants will be encouraged to undertake movements specifically prescribed to improve balance or increase strength. These activities will be embedded within everyday activities; so that the movements can be done several times during the day rather than a prescribed set of exercises conducted for a set amount of time. The duration of the CTM intervention will be 8 weeks. During the initial 8 weeks, the research physiotherapist will work with the home care worker (i.e. CTM Motivator) and the participant (i.e. home care client) to demonstrate how the movements can be completed safely and effectively over three visits. A fourth follow-up visit will then be completed by the research physiotherapist after 6 months to complete the final assessment. Over the study period, it will be the role of the home care worker to encourage and prompt the participant to engage in the CTM programme on their home care visits, which will occur at least once a week. Participants will be asked to complete a weekly report to be collected by the home care worker in which they will monitor any falls or major health changes and health care use. Participants will be given a weekly calendar to tick each day they performed an activity during the study period. The primary outcomes will be based on the feasibility of the CTM intervention and data collection across the study period. The primary outcome of the future definitive RCT will be decided by the responsiveness to change, participant burden and participant feedback from this study. The researchers will document data loss in the questionnaires and tests within the secondary outcome measures and document any adverse events related to the CTM intervention.They will produce a logic model for implementation that can be tested in a future study. They will examine the implementation and running cost of the CTM programme. Baseline demographic and outcome variables will be described at all assessment times. The change in scores from baseline to T2 to T3 in the various outcome measures will be calculated. The health economic costs of the programme as well as the costs of other health and social care will be described. A decision analytic model will be developed using data from the performed data collection and supplemented with data from other sources. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Retention assessed using number of home care clients who are recruited and who provide data at 8 weeks and 6-month follow-up (retention) 2. Adherence assessed using engagement with CTM and progression over time using care documentation and the weekly calendar at 8 weeks and 6-month follow-up |
| Secondary outcome measures | 1. Functional performance assessed using the Timed Up and Go (TUG) test at baseline, 8 weeks and 6 months 2. Level of physical activity assessed using the PhoneFITT interview at baseline, 8 weeks and 6 months 3. Level of physical activity assessed using the Nottingham Extended Activities of Daily Living (NEADL) scale at baseline, 8 weeks and 6 months 4. Lower body strength assessed using the 30-second chair stand test at baseline, 8 weeks and 6 months 5. Balance confidence when moving assessed using the 10-item Activity-specific Balance Confidence (ABC) scale at baseline, 8 weeks and 6 months 6. Balance confidence assessed using the CONFBal scale at baseline, 8 weeks and 6 months 7. Quality of life assessed using SF-36 at baseline, 8 weeks and 6 months 8. Quality of life assessed using EuroQOL at baseline, 8 weeks and 6 months 9. Quality of life assessed using EQ5D-5L at baseline, 8 weeks and 6 months |
| Overall study start date | 01/04/2019 |
| Completion date | 31/08/2021 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 35 |
| Key inclusion criteria | 1. Recipient of low-level home care from a not-for-profit home care company located in Dublin 2. Aged 65 years or older 3. Clinical Frailty Score of 6 or less 4. Has fallen at least once in the last year 5. Receives ≤5 h of home care a week 6. Independently mobile (with or without a walking aid) |
| Key exclusion criteria | 1. Moderate to severe cognitive impairment 2. Any unstable clinical conditions 3. Receiving end of life care 4. Unable to safely follow instructions about exercising, moving or being more physically active |
| Date of first enrolment | 01/07/2019 |
| Date of final enrolment | 01/05/2021 |
Locations
Countries of recruitment
- Ireland
Study participating centres
Northside
Fairview
Dublin
-
Ireland
Main St
Ballymun Healthcare Facility
Dublin
-
Ireland
Sponsor information
University/education
Office of Research and Innovation
Ardilaun House
St Stephens Green
Dublin
2
Ireland
| Phone | +353 087 6245669 |
|---|---|
| mauricedowling@rcsi.ie | |
| Website | http://www.rcsi.ie/ |
"ROR" |
https://ror.org/01hxy9878 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Health Research Board, Ireland, An Bord Taighde Sláinte, HRB
- Location
- Ireland
Results and Publications
| Intention to publish date | 01/09/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | At the end of the project, anonymised files will be deposited in the Zenodo data repository. Raw data is available upon request from fhorgan@rcsi.ie. Data collection forms and patient consent forms are being held securely in the RCSI. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v2 | 24/05/2018 | 10/01/2020 | No | Yes |
| Protocol article | 01/03/2020 | 13/08/2021 | Yes | No | |
| Other publications | Older adults' perceptions of the intervention | 19/05/2022 | 12/07/2022 | Yes | No |
| Other publications | Perceptions of healthcare assistants delivering the intervention | 07/03/2022 | 12/07/2022 | Yes | No |
| Results article | 06/09/2022 | 12/09/2022 | Yes | No |
Additional files
- ISRCTN72605421_PIS_v2_24May2018.pdf
- Uploaded 10/01/2020
Editorial Notes
12/09/2022: Publication reference added.
12/07/2022: The following changes have been made:
1. Recruitment had been resumed.
2. Publication references added.
3. The IPD sharing statement and summary has been added.
08/07/2022: The intention to publish date has been changed from 28/02/2022 to 01/09/2022.
13/08/2021: Internal review.
12/05/2021: The following changes were made to the trial record:
1. The total final enrolment was added.
2. Publication reference added.
18/08/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/07/2020 to 01/05/2021.
2. The overall trial end date was changed from 31/10/2020 to 31/08/2021.
3. The intention to publish date was changed from 01/03/2021 to 28/02/2022.
17/04/2020: Due to current public health guidance, recruitment for this study has been paused.
10/01/2020: The participant information sheet has been uploaded.
08/01/2020: Trial's existence confirmed by the Royal College of Surgeons in Ireland Research Ethics Committee.
