Condition category
Signs and Symptoms
Date applied
18/12/2019
Date assigned
08/01/2020
Last edited
10/01/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 October 2020

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Frances Horgan

ORCID ID

http://orcid.org/0000-0002-8773-9953

Contact details

School of Physiotherapy
Royal College of Surgeons in Ireland
123 St Stephen's Green
Dublin
2
Ireland
+353 1 402 2472
fhorgan@rcsi.ie

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

HRB APA-2017-013

Study information

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

Acronym

Study hypothesis

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

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

Study design

Phase I non-randomized feasibility study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Home

Trial type

Treatment

Patient information sheet

No available in web format please contact the Principal Investigator fhorgan@rcsi.ie to request a copy of the participant information sheet.

Condition

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

Phase

Drug names

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 trial start date

01/04/2019

Overall trial end date

31/10/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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)

Participant type

Mixed

Age group

Senior

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

01/07/2019

Recruitment end date

01/07/2020

Locations

Countries of recruitment

Ireland

Trial participating centre

North Dublin Home Care
1 Marino Crescent Northside Fairview
Dublin
-
Ireland

Trial participating centre

Community Healthcare Organisation 9
Civic Building Main St Ballymun Healthcare Facility
Dublin
-
Ireland

Sponsor information

Organisation

Royal College of Surgeons in Ireland

Sponsor details

Office of Research and Innovation
Ardilaun House
St Stephens Green
Dublin
2
Ireland
+353 087 6245669
mauricedowling@rcsi.ie

Sponsor type

University/education

Website

http://www.rcsi.ie/

Funders

Funder type

Government

Funder name

Health Research Board

Alternative name(s)

THE HEALTH RESEARCH BOARD, HRB

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

Ireland

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date .

Intention to publish date

01/03/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.