NCT03505385

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 23, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 20, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
Last Updated

January 27, 2020

Status Verified

August 1, 2019

Enrollment Period

7 months

First QC Date

April 12, 2018

Last Update Submit

January 23, 2020

Conditions

Keywords

Co-creationService-learning methodology

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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).

  • Physical Function

    Outcome measure will be collected at baseline and at the end of the intervention (up to 24 weeks).

Study Arms (2)

Co-created intervention

EXPERIMENTAL

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: 1. 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). 2. 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). 3. 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)

Usual care

NO INTERVENTION

Interventions

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: 1. 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). 2. 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). 3. 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.

Co-created intervention

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • \- Care Home residents ≥ 70 years old.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Erskine Glasgow Home

Glasgow, G12 0BZ, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2018

First Posted

April 23, 2018

Study Start

May 20, 2019

Primary Completion

December 20, 2019

Study Completion

January 15, 2020

Last Updated

January 27, 2020

Record last verified: 2019-08

Locations