Older Adults With Cognitive Impairment Doing Sit to Stands, Walking in Transitional Care Programs: A Feasibility Study

Dementia Clinical Trial

— OASIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06150339
• Other study ID #: 23-5543
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: October 2024

Study information

• Verified date: October 2023
• Source: University Health Network, Toronto
• Contact: Katherine S McGilton, PhD
• Phone: 416 597 3422
• Email: kathy.mcgilton[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

2. have Parkinson's disease as documented in the medical chart (due to impairments in muscle and motor function)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Delirium
• Dementia
• Functional Decline

Intervention

Other:
• OASIS Walking Intervention
Communication Care Plan, Sit to Stand Activity, Walking Program

Locations

Country	Name	City	State
Canada	Abbeylawn Retirement Home Transitional Care Unit (Operated by Bayshore Health Care)	Pickering	Ontario
Canada	Cedarbrook Lodge Retirement Home Transitional Care Unit (Operated by Bayshore Health Care)	Scarborough	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Recruitment rate will be calculated as the percentage of participants who enroll in the study out of the total number of eligible participants	From start of recruitment to end of recruitment (6 months)
Primary	Retention rate	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)	Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)
Primary	Adherence (Level of engagement with the treatment [percentage]).	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)	Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)
Primary	Adherence (Average number of treatment sessions attended)	Average number of treatment sessions attended	Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)
Primary	Adherence (Average duration of each intervention session)	The average duration of each intervention session (in minutes)	Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)
Primary	Adherence (Average duration of each walking session)	The average duration of each walking session (in minutes)	Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)
Primary	Adherence (Average number of sit to stands done per session)	Average number of sit to stands done per session.	Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)
Primary	Adherence (Level of engagement with sit to stands [percentage])	Percentage = number of sit to stands done per session, divided by the goal number of sit to stands.	Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)
Secondary	Participant Satisfaction	8-Item Client Satisfaction Questionnaire (CSQ-8) + 3 Open-Ended Questions. The CSQ-8 has a minimum value is 8, the maximum value is 32. Higher scores mean a better outcome.	Posttest (Immediately after 6-week intervention) (Time 3)
Secondary	Lower extremity muscle strength	time to perform one sit-to-stand	Pretest Initial Assessment (Time 1); After 3 weeks of intervention (Time 2); Posttest (Immediately after 6-week intervention) (Time 3)
Secondary	Mobility	2-minute walk test	Pretest Initial Assessment (Time 1); After 3 weeks of intervention (Time 2); Posttest (Immediately after 6-week intervention) (Time 3)
Secondary	Functional Status	Barthel Index (BI). The BI has a minimum value of 0 and a maximum value of 20. Higher scores mean a better outcome.	Pretest Initial Assessment (Time 1); After 3 weeks of intervention (Time 2); Posttest (Immediately after 6-week intervention) (Time 3)
Secondary	Patient's Quality of Life	The Quality of Life-AD Measure (QOL-AD). The QOL-AD is a 13-item questionnaire. Participants rate each item on a 4-point scale, with 1 being poor and 4 being excellent. The minimum score is 13 and the maximum score is 52. Higher scores mean a better outcome.	Pretest Initial Assessment (Time 1); After 3 weeks of intervention (Time 2); Posttest (Immediately after 6-week intervention) (Time 3)
Secondary	Discharge destination	Discharge destination after TCP	At the time of discharge from the TCU or within 60 days of admission to TCP, whichever comes first.
Secondary	Intervention fidelity (percentage)	Intervention fidelity will also be measured through the interventionist's self-report of 12 intervention items. The percentage will be calculated as the number of items done divided by the 12 items on the intervention fidelity checklist. Minimum value is 0%, maximum value is 100%. A higher percentage means a better outcome (greater intervention fidelity).	Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)