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临床试验/NCT03505385
NCT03505385已完成不适用

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

Glasgow Caledonian University1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2019年5月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
1
主要终点
Change in sitting time

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •- Care Home residents ≥ 70 years old.

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Co-created intervention - Get Ready (GR) (Behavioral)

Usual care

No Intervention

结局指标

主要结局

Change in sitting time

时间窗: 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.

Change in minutes spent in sedentary behaviour

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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