Clinical trial NCT03505385: Effects of a Unique Co-created Intervention With Care Home Residents and University Students Following a Service-learning Methodology to Reduce Sedentary Behaviour.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Sedentary Behaviour
Care Home Residents
Keywords: Co-creation
Service-learning methodology
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
First posted: 2018-04-23
Enrollment: 33
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

- Care Home residents ≥ 70 years old.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in minutes spent in sedentary behaviour
timeFrame: During 7 days. Outcome measure will be collected at baseline and at the end of the intervention (up to 24 weeks)
measure: Change in sitting time
timeFrame: During 7 days. Outcome measure will be collected at baseline and at the end of the intervention (up to 24 weeks).
Secondary outcomes:
measure: Change in health-related quality of life
timeFrame: Outcome measure will be collected at baseline and at the end of the intervention (up to 24 weeks).
measure: Physical Function
timeFrame: Outcome measure will be collected at baseline and at the end of the intervention (up to 24 weeks).
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: The Erskine Glasgow Home
Study officials:
References:
citation: 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.