Clinical trial NCT06150339: Older Adults With Cognitive Impairment Doing Sit to Stands, Walking in Transitional Care Programs: A Feasibility Study
Official title: The OASIS Walking Study - Older Adults With Cognitive Impairment Performing Sit to Stands and Walking in Transitional Care Programs: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Dementia
Delirium
Functional Decline
Keywords: Cognitive Impairment
Dementia
Delirium
Functional Decline
Walking
Walking Program
Activity
Sit to Stand
Chair Stand
Nurse-led
Mobility
Feasibility
Intervention
Quasi-experimental
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-11-29
Enrollment: 26
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is a feasibility study which will use a quasi-experimental one group time series design.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

For patients in the Long-Term Care Stream or Rehab Stream Arm, the dose of the intervention is: up to 45 minutes per session, five sessions per week, for six 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-stand activity.

For patients in the Reactivation Stream Intervention Arm, the dose of the intervention is: up to 45 minutes per session, five sessions per week, for three 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-stand activity.

Eligibility criteria: Inclusion Criteria:

1. aged 65 years and older;
2. 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)
3. admitted to a transitional care unit after a hospitalization
4. can speak English
5. has received clearance from the physiotherapist to participate in the study
6. has received clearance from the nurse practitioner to participate in the study
7. were community-dwelling (lived in a home or retirement home; not a nursing home) prior to hospitalization
8. were able to walk independently or with the assistance of one person (with or without a gait aid) prior to hospital admission
9. is currently able to ambulate either independently or with the assistance of one person (with or without a gait aid)
10. has a care partner (family member, friend) who is willing participate in an interview about the patient for the study.

Exclusion Criteria:

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

Primary outcomes:
measure: Recruitment rate
timeFrame: From start of recruitment to end of recruitment (6 months)
measure: Retention rate
timeFrame: Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)
measure: Adherence (Level of engagement with the treatment [percentage]).
timeFrame: Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)
measure: Adherence (Average number of treatment sessions attended)
timeFrame: Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)
measure: Adherence (Average duration of each intervention session)
timeFrame: Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)
measure: Adherence (Average duration of each walking session)
timeFrame: Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)
measure: Adherence (Average number of sit to stands done per session)
timeFrame: Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)
measure: Adherence (Level of engagement with sit to stands [percentage])
timeFrame: Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)
Secondary outcomes:
measure: Participant Satisfaction (for Long-Term Care Stream or Rehab Stream Arm)
timeFrame: Posttest (Immediately after 6-week intervention) (Time 3)
measure: Participant Satisfaction (for Reactivation Stream Intervention Arm)
timeFrame: Posttest (Immediately after 3-week intervention) (Time 3)
measure: Lower extremity muscle strength (for Long-Term Care Stream or Rehab Stream Arm)
timeFrame: Pretest Initial Assessment (Time 1); After 3 weeks of intervention (Time 2); Posttest (Immediately after 6-week intervention) (Time 3)
measure: Lower extremity muscle strength (for Reactivation Stream Intervention Arm)
timeFrame: Pretest Initial Assessment (Time 1); After 1.5 weeks of intervention (Time 2); Posttest (Immediately after 3-week intervention) (Time 3)
measure: Mobility (for Long-Term Care Stream or Rehab Stream Arm)
timeFrame: Pretest Initial Assessment (Time 1); After 3 weeks of intervention (Time 2); Posttest (Immediately after 6-week intervention) (Time 3)
measure: Mobility (for Reactivation Stream Intervention Arm)
timeFrame: Pretest Initial Assessment (Time 1); After 1.5 weeks of intervention (Time 2); Posttest (Immediately after 3-week intervention) (Time 3)
measure: Functional Status (for Long-Term Care Stream or Rehab Stream Arm)
timeFrame: Pretest Initial Assessment (Time 1); After 3 weeks of intervention (Time 2); Posttest (Immediately after 6-week intervention) (Time 3)
measure: Functional Status (for Reactivation Stream Intervention Arm)
timeFrame: Pretest Initial Assessment (Time 1); After 1.5 weeks of intervention (Time 2); Posttest (Immediately after 3-week intervention) (Time 3)
measure: Patient's Quality of Life (for Long-Term Care Stream or Rehab Stream Arm)
timeFrame: Pretest Initial Assessment (Time 1); After 3 weeks of intervention (Time 2); Posttest (Immediately after 6-week intervention) (Time 3)
measure: Discharge destination (for Long-Term Care Stream or Rehab Stream Arm)
timeFrame: At the time of discharge from the TCU or within 60 days of admission to TCP, whichever comes first.
measure: Discharge destination (for Reactivation Stream Intervention Arm)
timeFrame: At the time of discharge from the TCU or within 60 days of admission to TCP, whichever comes first.
measure: Intervention fidelity (percentage)
timeFrame: Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)
Other outcomes:
Locations:
city: Pickering
country: Canada
facility: Abbeylawn Retirement Home Transitional Care Unit (Operated by Bayshore Health Care)
state: Ontario
city: Scarborough
country: Canada
facility: Cedarbrook Lodge Retirement Home Transitional Care Unit (Operated by Bayshore Health Care)
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Katherine S McGilton, PhD
role: PRINCIPAL_INVESTIGATOR
References: