GET READY: Effects of a Unique Co-created Intervention With Care Home Residents and University Students Following a Service-learning Methodology to Reduce Sedentary Behaviour.

Sponsor
Glasgow Caledonian University (Other)
Overall Status
Completed
CT.gov ID
NCT03505385
Collaborator
(none)
33
1
2
7.9
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Co-created intervention - Get Ready (GR)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
33 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.
Actual Study Start Date :
May 20, 2019
Actual Primary Completion Date :
Dec 20, 2019
Actual Study Completion Date :
Jan 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Co-created intervention

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.

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: 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.

No Intervention: Usual care

Outcome Measures

Primary Outcome Measures

  1. Change in minutes spent in sedentary behaviour [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 [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 [Outcome measure will be collected at baseline and at the end of the intervention (up to 24 weeks).]

    EuroQoL - 5D

  2. Physical Function [Outcome measure will be collected at baseline and at the end of the intervention (up to 24 weeks).]

    Short Physical Performance Battery

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Erskine Glasgow Home Glasgow United Kingdom G12 0BZ

Sponsors and Collaborators

  • Glasgow Caledonian University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Glasgow Caledonian University
ClinicalTrials.gov Identifier:
NCT03505385
Other Study ID Numbers:
  • 747490
First Posted:
Apr 23, 2018
Last Update Posted:
Jan 27, 2020
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Glasgow Caledonian University

Study Results

No Results Posted as of Jan 27, 2020