Effects of a Unique Co-created Intervention With Care Home Residents and University Students Following a Service-learning Methodology to Reduce Sedentary Behaviour. (GET READY)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03505385|
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : September 3, 2019
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 60 care home residents, within a two-armed pragmatic randomized clinical trial.
|Condition or disease||Intervention/treatment||Phase|
|Physical Activity Sedentary Behaviour Care Home Residents||Behavioral: Co-created intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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.|
|Actual Study Start Date :||May 20, 2019|
|Estimated Primary Completion Date :||October 20, 2019|
|Estimated Study Completion Date :||January 22, 2020|
Experimental: Co-created intervention
Stage 1. Workshops and co-creation protocol. A purposive sampling strategy will be used to identify a total of 5 to 6 residents living in one care home in Glasgow and in one care home in Barcelona. The service-learning methodology will be integrated within a current module in the Physical Therapy degree in a University located in Glasgow and in the Sport Sciences degree in a University located in Barcelona. A group of students will be involved in the design of two workshops for care home residents. After the two workshops, we will conduct two discussion groups. The first discussion group will be conducted by the same three to four students with researcher supervision. The second discussion group will be conducted by the same students, two researchers, three health professionals working in the care home (e.g. physical therapist, nurse, occupational therapist, geriatrician), one caregiver, one family member, and one policy maker will be invited.
Behavioral: Co-created intervention
The intervention will be co-created with care home residents and staff working in the Care Homes, relatives and relevant stakeholders (including policy makers), following the aforementioned protocol (stage 1 of the study). The co-creation stage will allow us determine the intervention ready to be tested in a pilot randomized clinical trial.
|No Intervention: Usual care|
- 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.
- 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). ]ICECAP-O questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505385
|The Erskine Glasgow Home||Recruiting|
|Glasgow, United Kingdom, G12 0BZ|
|Contact: Janet Leith, PT 0044 0141 814 4547 email@example.com|
|Principal Investigator: Maria Giné-Garriga, PhD|
|Principal Investigator: Dawn Skelton, MD, PhD|