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Completed

NCT Number: NCT03505385

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

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Erskine Glasgow Home

Glasgow, G12 0BZ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Co-created intervention - Get Ready (GR)

Behavioral

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.

Primary outcomes

  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 outcomes

  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).

    EuroQoL - 5D

  2. Physical Function

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

    Short Physical Performance Battery

Sponsors and collaborators

Lead sponsor

Glasgow Caledonian University

Other

Registry information

Acronym: GET READY

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Apr 23, 2018
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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