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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Delirium; Cognitive Impairment; Dementia; Functional Decline
• Intervention / Treatment: Other: OASIS Walking Intervention

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.

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.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine S McGilton, PhD; Phone Number: 2500 416 597 3422; Email: kathy.mcgilton@uhn.ca
• Study Contact Backup: Name: Tracey JF Colella, PhD; Phone Number: 5234 416 597 3422; Email: tracey.colella@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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.
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)

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Katherine S McGilton, PhD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 29, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Feasibility; Cognitive Impairment; Dementia; Walking; Intervention; Mobility; Nurse-led; Delirium; Activity; Functional Decline; Quasi-experimental; Sit to Stand; Walking Program; Chair Stand
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Delirium; Dementia; Cognitive Dysfunction
• Other Study ID Numbers: 23-5543

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available upon request Beginning 9 months and ending 36 months following article publication to Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose for the purpose of individual participant data meta-analysis.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No