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

Physical Activity Clinical Trial

— GET READY  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03505385
• Other study ID #: 747490
• Status: Completed
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: January 15, 2020

Study information

• Verified date: August 2019
• Source: Glasgow Caledonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 15, 2020
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Care Home Residents
• Physical Activity
• Sedentary Behaviour

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	The Erskine Glasgow Home	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
Glasgow Caledonian University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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).
Secondary	Physical Function	Short Physical Performance Battery	Outcome measure will be collected at baseline and at the end of the intervention (up to 24 weeks).