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临床试验/NCT06150339
NCT06150339已完成不适用

The OASIS Walking Study - Older Adults With Cognitive Impairment Performing Sit to Stands and Walking in Transitional Care Programs: A Feasibility Study

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2024年3月1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
6
试验地点
2
主要终点
Retention rate

研究概览

简要总结

The goal of this intervention study is to test the effects of a nurse-led mobility intervention (known as the OASIS Walking Intervention (Older Adults performing Sit to Stands and Walking Intervention)) in older adults with cognitive impairment, such as dementia, in transitional care programs.

The main questions this study aims to answer are:

  • Is the study doable and are older adults satisfied with the intervention?
  • Does the intervention improve older adults' muscle strength, mobility, functional status and quality of life?

Participants will be asked to do the following:

  1. Be interviewed once so that a patient-centred communication care plan can be made
  2. Do sit to stand activity
  3. Walk as part of a walking program.

详细描述

The purpose of this study is to determine the feasibility of and satisfaction of participants with a novel intervention - the OASIS Walking Intervention (that is, the Older Adults with cognitive impairment performing Sit to Stands and Walking Intervention) in a facility-based TCPs.

The second aim is to determine the efficacy of the OASIS Walking intervention on muscle strength, mobility, functional status, quality of life, and discharge destination.

A feasibility study will be undertaken for this three-component intervention project. In terms of study design, a quasi-experimental one group time series design will be used.

A sample size of 26 patient participants and their substitute decision makers will participate in the study. Participants will be older adults ≥65 years admitted to a facility-based transitional care unit in Ontario.

The Older Adults with cognitive impairment performing the Sit to Stands and Walking Intervention is a nurse-led intervention that consists of three components: 1) Patient-Centered Communication Care Plan (informed by interviews with the participant and their care partner); 2) Sit to Stand Activity; and 3) Walking program. This intervention is grounded using a patient centered approach.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • •aged 65 years and older;
  • •have cognitive impairment (dementia, delirium, cognitive impairment, or unspecified cognitive impairment) as documented in the medical record or Quick Dementia Rating Scale (QDRS) score of ≥2)
  • •admitted to a transitional care unit after a hospitalization
  • •can speak English
  • •has received clearance from the physiotherapist to participate in the study
  • •has received clearance from the nurse practitioner to participate in the study
  • •were community-dwelling (lived in a home or retirement home; not a nursing home) prior to hospitalization
  • •were able to walk independently or with the assistance of one person (with or without a gait aid) prior to hospital admission
  • •is currently able to ambulate either independently or with the assistance of one person (with or without a gait aid)
  • •has a care partner (family member, friend) who is willing participate in an interview about the patient for the study.

排除标准

  • •1) Palliative (having <six months prognosis as documented in the medical chart)

研究组 & 干预措施

Long-term Care Stream or Rehab Stream Intervention Arm

Experimental

Intervention Dose: Up to 45 minutes per session, 5 sessions per week, for 6 weeks. Approximately up to 30 minutes will be spent walking; up to 15 minutes will be spent performing sit-to-stands.

Intervention Components:

Component 1: Patient-Centered Communication Care Plan. A patient-centered communication care plan will be created, to promote enjoyment and engagement during the sessions. The care plan will be informed by interviews with the participant and their care partner.

Component 2: Sit to Stand Activity. A target number of sit to stands per session will be determined based on a baseline assessment and according to an algorithm; the target will be progressed halfway into the intervention.

Component 3: Walking Program. Based on the findings from the patient-centered assessment interviews as well as the performance of the participants on a walk test at baseline (Time 1), an individualized walking program will be carried out with participants.

干预措施: OASIS Walking Intervention (Other)

Reactivation Stream Intervention Arm

Experimental

Intervention Dose: up to 45 minutes per session, five sessions per week, for 3 weeks. Approximately up to 30 minutes will be spent walking with the participant and up to 15 minutes will be spent performing the sit-to-stands.

Component 1: Patient-Centered Communication Care Plan. A patient-centered communication care plan will be created, to promote enjoyment and engagement during the sessions. The care plan will be informed by interviews with the participant and their care partner.

Component 2: Sit to Stand Activity. A target number of sit to stands per session will be determined based on a baseline assessment and according to an algorithm; the target will be progressed halfway into the intervention.

Component 3: Walking Program. Based on the findings from the patient-centered assessment interviews as well as the performance of the participants on a walk test at baseline (Time 1), an individualized walking program will be carried out with participants.

干预措施: OASIS Walking Intervention (Other)

结局指标

主要结局

Retention rate

时间窗: Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)

Retention rate will be calculated as the percentage of participants who complete the study (i.e., receive the full dose of the intervention and provided post-test outcome data) out of the number of participants who were enrolled (i.e., signed a consent form and provided baseline data)

Adherence (Average number of treatment sessions attended)

时间窗: Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)

Average number of treatment sessions attended

Adherence (Average duration of each walking session)

时间窗: Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)

The average duration of each walking session (in minutes)

Recruitment rate

时间窗: From start of recruitment to end of recruitment (6 months)

Recruitment rate will be calculated as the percentage of participants who enroll in the study out of the total number of eligible participants

Adherence (Level of engagement with the treatment [percentage]).

时间窗: Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)

The level of engagement with the treatment (percentage). For this study, the planned number of sessions is five per week for 6 weeks for a total of 30 sessions. Percentage = the number of sessions attended divided by the total number of sessions (30 sessions)

Adherence (Average duration of each intervention session)

时间窗: Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)

The average duration of each intervention session (in minutes)

Adherence (Level of engagement with sit to stands [percentage])

时间窗: Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)

Percentage = number of sit to stands done per session, divided by the goal number of sit to stands.

Adherence (Average number of sit to stands done per session)

时间窗: Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)

Average number of sit to stands done per session.

次要结局

  • Participant Satisfaction (for Long-Term Care Stream or Rehab Stream Arm)(Posttest (Immediately after 6-week intervention) (Time 3))
  • Participant Satisfaction (for Reactivation Stream Intervention Arm)(Posttest (Immediately after 3-week intervention) (Time 3))
  • Lower extremity muscle strength (for Long-Term Care Stream or Rehab Stream Arm)(Pretest Initial Assessment (Time 1); After 3 weeks of intervention (Time 2); Posttest (Immediately after 6-week intervention) (Time 3))
  • Lower extremity muscle strength (for Reactivation Stream Intervention Arm)(Pretest Initial Assessment (Time 1); After 1.5 weeks of intervention (Time 2); Posttest (Immediately after 3-week intervention) (Time 3))
  • Mobility (for Long-Term Care Stream or Rehab Stream Arm)(Pretest Initial Assessment (Time 1); After 3 weeks of intervention (Time 2); Posttest (Immediately after 6-week intervention) (Time 3))
  • Mobility (for Reactivation Stream Intervention Arm)(Pretest Initial Assessment (Time 1); After 1.5 weeks of intervention (Time 2); Posttest (Immediately after 3-week intervention) (Time 3))
  • Functional Status (for Long-Term Care Stream or Rehab Stream Arm)(Pretest Initial Assessment (Time 1); After 3 weeks of intervention (Time 2); Posttest (Immediately after 6-week intervention) (Time 3))
  • Functional Status (for Reactivation Stream Intervention Arm)(Pretest Initial Assessment (Time 1); After 1.5 weeks of intervention (Time 2); Posttest (Immediately after 3-week intervention) (Time 3))
  • Patient's Quality of Life (for Long-Term Care Stream or Rehab Stream Arm)(Pretest Initial Assessment (Time 1); After 3 weeks of intervention (Time 2); Posttest (Immediately after 6-week intervention) (Time 3))
  • Discharge destination (for Long-Term Care Stream or Rehab Stream Arm)(At the time of discharge from the TCU or within 60 days of admission to TCP, whichever comes first.)
  • Discharge destination (for Reactivation Stream Intervention Arm)(At the time of discharge from the TCU or within 60 days of admission to TCP, whichever comes first.)
  • Intervention fidelity (percentage)(Calculated at the end of the study (6 months + 6 weeks from the start of recruitment))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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