Physical ActivityGET READYNCT03505385
Effects of a Unique Co-created Intervention With Care Home Residents and University Students Following a Service-learning Methodology to Reduce Sedentary Behaviour.
A study testing Co-created intervention - Get Ready (GR) in people with Physical Activity and Sedentary Behaviour, run by Glasgow Caledonian University at 1 site in United Kingdom.
Trial summary
Background. There is a growing demand for long-term care settings. Care-home residents are a vulnerable group with high levels of physical dependency and cognitive impairment. Long-term care facilities' policy need to adapt and offer more effective and sustainable interventions to address their complex physical and… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Physical Activity, Sedentary Behaviour, Care Home Residents
- What is being tested?
- Co-created intervention - Get Ready (GR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 May 2019to 15 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Care Home residents ≥ 70 years old.
Who cannot join
- Comorbidity preventing participation (e.g. severe breathlessness, pain, or severe neurological disease).
- Life expectancy of less than one year.
- Being unlikely to undertake the intervention regularly.
- Severe dementia.
Trial locations and contacts
1 site in 1 country.
About this study
Background. There is a growing demand for long-term care settings. Care-home residents are a vulnerable group with high levels of physical dependency and cognitive impairment. Long-term care facilities' policy need to adapt and offer more effective and sustainable interventions to address their complex physical and mental health needs. Despite the increasing emphasis on patient and public involvement, marginalised groups such as care-home residents, can be overlooked when including people in the research process. The GET READY project aims to integrate service-learning methodology into Physical Therapy and Sport Sciences University degrees by offering students individual service opportunities (placements) with residential care homes, in order to co-create the best suited intervention with researchers, older adults of both genders (end-users) in care homes, health professionals, caregivers, family members and policy makers.
Methods. Stage 1 will integrate a service-learning methodology within a Physical Therapy module in Glasgow and Sport Sciences module in Barcelona, design two workshops for care home residents and conduct a co-creation protocol. Stage 2 will assess the intervention feasibility, safety and preliminary effects of the co-created intervention in a group of 33 care home residents, within a two-armed pragmatic randomized clinical trial.
- Conditions
- Physical Activity, Sedentary Behaviour, Care Home Residents
- Being tested
- Co-created intervention - Get Ready (GR)
- Keywords
- Co-creation, Service-learning methodology
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-created intervention - Get Ready (GR)Behavioural
The Get Ready (GR) intervention was delivered one-to-one with the care home resident and a relevant family member during a 12-week period:
- The familiarisation stage aimed to build a rapport with two long-term achievement goals to sit less and move more with the resident and the family member and consisted of two sessions, one in week 1 (50-60minutes) and the other in week 3 (30-40 minutes).
- The ramping up stage aimed to review the rapport and reach an achievable consensus with the resident and the family member. It consisted of two sessions, one in week 5 and the other in week 7 (20-30 minutes each).
- The maintenance stage aimed at integrating behaviours and included two sessions, one in week 9 and the other at week 12 (20-30 minutes each). Sessions 5 and 6 were used to understand how the resident was getting on with their short-term GR goals, facilitating some problem-solving discussions.
| Study group | Role | What they receive |
|---|---|---|
| Co-created intervention | Experimental | The Get Ready (GR) intervention was delivered one-to-one with the care home resident and a relevant family member during a 12-week period:
1. The familiarisation stage aimed to build a rapport with two long-term achievement goals to sit less and move more with the resident and the family member and consisted of two sessions, one in week 1 (50-60minutes) and the other in week 3 (30-40 minutes).
2. The ramping up stage aimed to review the rapport and reach an achievable consensus with the resident and the family member. It consisted of two sessions, one in week 5 and the other in week 7 (20-30 minutes each).
3. The maintenance stage aimed at integrating behaviours and included two sessions, one in week 9 and the other at week 12 (20-30 minutes each). Sessions 5 and 6 were used to understand how the resident was getting on with their short-term GR goals, facilitating some problem-solving discussions. Receives: Behavioral: Co-created intervention - Get Ready (GR) |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in minutes spent in sedentary behaviour
Number of minutes spent in activities requiring ≤ Metabolic Equivalent Tasks with ActivPal monitor.
Measured: During 7 days. Outcome measure will be collected at baseline and at the end of the intervention (up to 24 weeks)
Change in sitting time
Number of minutes spent in a sitting position with ActivPal monitor.
Measured: During 7 days. Outcome measure will be collected at baseline and at the end of the intervention (up to 24 weeks).
Secondary outcomes (2)
Change in health-related quality of life
EuroQoL - 5D
Measured: Outcome measure will be collected at baseline and at the end of the intervention (up to 24 weeks).
Physical Function
Short Physical Performance Battery
Measured: Outcome measure will be collected at baseline and at the end of the intervention (up to 24 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start20 May 2019
- Primary completion20 Dec 2019
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505385
- Sponsor's protocol ID
- 747490
- Acronym
- GET READY
- Status last verified
- Aug 2019
- First submitted
- 12 Apr 2018
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gine-Garriga M, Sandlund M, Dall PM, Chastin SFM, Perez S, Skelton DA. A co-created intervention with care home residents and university students following a service-learning methodology to reduce sedentary behaviour: The GET READY project protocol. J Frailty Sarcopenia Falls. 2018 Sep 1;3(3):132-137. doi: 10.22540/JFSF-03-132. eCollection 2018 Sep.
PubMed 32300702
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Unique Co-created Intervention With Care Home Residents and University Students Following a Service-learning Methodology to Reduce Sedentary Behaviour.
- ClinicalTrials.gov ID
- NCT03505385
- Acronym / sponsor ID
- GET READY / 747490
- Conditions
- Physical Activity, Sedentary Behaviour, Care Home Residents
- Keywords
- Co-creation, Service-learning methodology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 23 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background. There is a growing demand for long-term care settings. Care-home residents are a vulnerable group with high levels of physical dependency and cognitive impairment. Long-term care facilities' policy need to adapt and offer more effective and sustainable interventions to address their complex physical and mental health needs. Despite the increasing emphasis on patient and public involvement, marginalised groups such as care-home residents, can be overlooked when including people in the research process. The GET READY project aims to integrate service-learning methodology into Physical Therapy and Sport Sciences University degrees by offering students individual service opportunities (placements) with residential care homes, in order to co-create the best suited intervention with researchers, older adults of both genders (end-users) in care homes, health professionals, caregivers, family members and policy makers.
Methods. Stage 1 will integrate a service-learning methodology within a Physical Therapy module in Glasgow and Sport Sciences module in Barcelona, design two workshops for care home residents and conduct a co-creation protocol. Stage 2 will assess the intervention feasibility, safety and preliminary effects of the co-created intervention in a group of 33 care home residents, within a two-armed pragmatic randomized clinical trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Co-created intervention | Experimental | Behavioral: Co-created intervention - Get Ready (GR)The Get Ready (GR) intervention was delivered one-to-one with the care home resident and a relevant family member during a 12-week period: 1. The familiarisation stage aimed to build a rapport with two long-term achievement goals to sit less and move more with the resident and the family member and consisted of two sessions, one in week 1 (50-60minutes) and the other in week 3 (30-40 minutes). 2. The ramping up stage aimed to review the rapport and reach an achievable consensus with the resident and the family member. It consisted of two sessions, one in week 5 and the other in week 7 (20-30 minutes each). 3. The maintenance stage aimed at integrating behaviours and included two sessions, one in week 9 and the other at week 12 (20-30 minutes each). Sessions 5 and 6 were used to understand how the resident was getting on with their short-term GR goals, facilitating some problem-solving discussions. |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Care Home residents ≥ 70 years old.
Key exclusion criteria (4 listed)
- Comorbidity preventing participation (e.g. severe breathlessness, pain, or severe neurological disease).
- Life expectancy of less than one year.
- Being unlikely to undertake the intervention regularly.
- Severe dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Co-created intervention - Get Ready (GR)The Get Ready (GR) intervention was delivered one-to-one with the care home resident and a relevant family member during a 12-week period: 1. The familiarisation stage aimed to build a rapport with two long-term achievement goals to sit less and move more with the resident and the family member and consisted of two sessions, one in week 1 (50-60minutes) and the other in week 3 (30-40 minutes). 2. The ramping up stage aimed to review the rapport and reach an achievable consensus with the resident and the family member. It consisted of two sessions, one in week 5 and the other in week 7 (20-30 minutes each). 3. The maintenance stage aimed at integrating behaviours and included two sessions, one in week 9 and the other at week 12 (20-30 minutes each). Sessions 5 and 6 were used to understand how the resident was getting on with their short-term GR goals, facilitating some problem-solving discussions. | Behavioural | Co-created intervention |
Primary outcome
Change in minutes spent in sedentary behaviour
Time frame: During 7 days. Outcome measure will be collected at baseline and at the end of the intervention (up to 24 weeks)
Number of minutes spent in activities requiring ≤ Metabolic Equivalent Tasks with ActivPal monitor.
Change in sitting time
Time frame: During 7 days. Outcome measure will be collected at baseline and at the end of the intervention (up to 24 weeks).
Number of minutes spent in a sitting position with ActivPal monitor.
2 secondary outcomes
Change in health-related quality of life
Time frame: Outcome measure will be collected at baseline and at the end of the intervention (up to 24 weeks).
Physical Function
Time frame: Outcome measure will be collected at baseline and at the end of the intervention (up to 24 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Derived from this study: PubMed 32300702Gine-Garriga M, Sandlund M, Dall PM, Chastin SFM, Perez S, Skelton DA. A co-created intervention with care home residents and university students following a service-learning methodology to reduce sedentary behaviour: The GET READY project protocol. J Frailty Sarcopenia Falls. 2018 Sep 1;3(3):132-137. doi: 10.22540/JFSF-03-132. eCollection 2018 Sep.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Co-created intervention - Get Ready (GR) in people with Physical Activity and Sedentary Behaviour, run by Glasgow Caledonian University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in minutes spent in sedentary behaviour (time frame: During 7 days. Outcome measure will be collected at baseline and at the end of the intervention (up to 24 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03505385, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.