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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)

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ClinicalTrials.gov Identifier: NCT03505385
Recruitment Status : Not yet recruiting
First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Glasgow Caledonian University

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 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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.
Estimated Study Start Date : January 15, 2019
Estimated Primary Completion Date : June 20, 2019
Estimated Study Completion Date : January 22, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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United Kingdom
The Erskine Glasgow Home Not yet recruiting
Glasgow, United Kingdom, G12 0BZ
Contact: Janet Leith, PT    0044 0141 814 4547    janet.leith@erskine.org.uk   
Principal Investigator: Maria Giné-Garriga, PhD         
Principal Investigator: Dawn Skelton, MD, PhD         
Sponsors and Collaborators
Glasgow Caledonian University

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Responsible Party: Glasgow Caledonian University
ClinicalTrials.gov Identifier: NCT03505385     History of Changes
Other Study ID Numbers: 747490
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Glasgow Caledonian University:
Co-creation
Service-learning methodology