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)

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 Overview

• Status: Completed
• Conditions: Physical Activity; Sedentary Behaviour; Care Home Residents
• Intervention / Treatment: Behavioral: Co-created intervention - Get Ready (GR)

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom, G12 0BZ
    • The Erskine Glasgow Home

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in minutes spent in sedentary behaviour	Number of minutes spent in activities requiring ≤ Metabolic Equivalent Tasks with ActivPal monitor.	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.	During 7 days. Outcome measure will be collected at baseline and at the end of the intervention (up to 24 weeks).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in health-related quality of life	EuroQoL - 5D	Outcome measure will be collected at baseline and at the end of the intervention (up to 24 weeks).
Physical Function	Short Physical Performance Battery	Outcome measure will be collected at baseline and at the end of the intervention (up to 24 weeks).

Collaborators and Investigators

• Sponsor: Glasgow Caledonian University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): December 20, 2019
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: April 20, 2018
• First Posted (Actual): April 23, 2018

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 23, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Co-creation; Service-learning methodology
• Other Study ID Numbers: 747490

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No