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E-health Enhanced Motor-cognitive Training for AED Discharged Older Adults With Cognitive Frailty

Primary Purpose

Frailty, Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
E-health enhanced motor-cognitive training
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Frailty focused on measuring Cognitive frailty, Motor-Cognitive Training, Older Adults, Discharged

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged 60 years old or above; discharged from the AED; Cantonese speaking; have a smartphone and have experience in using the smartphone for at least six months; with cognitive frailty, the coexistence of mild cognitive impairment (MCI) and physical frailty, without being diagnosed as dementia. Exclusion Criteria: unable to make consent, unable to communicate due to language barrier or visual impairment or uncorrectable hearing impairment, old aged home residents, already participated in other interventional studies, participate in any geriatric program and training, or impaired mobility

Sites / Locations

  • School of Nursing, The Hong Kong Polytechnic UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment group

Usual care group

Arm Description

The intervention group will receive home-based motor-cognitive training and usual emergency care.

Usual care includes wound care, community nurse service, medications and on-site physiotherapy, occupational therapy, community nurse service, medical social work service, and geriatric nurse follow-up service will be referred when necessary.

Outcomes

Primary Outcome Measures

Recruitment rate
One of the feasibility outcomes. It is the overall recruitment rate, which will be calculated by dividing the number of recruited and randomized, by the total invited eligible potential participants. It will range from 0 to 100%.
Retention rate
One of the feasibility outcomes. It is calculated by dividing the number of randomised participants retained and assessed with valid primary outcome data at the end of the project, by the recruited participants. It will range from 0 to 100%.
Adverse events
A feasibility indicators, which is defined as an undesired effect of the intervention. Any adverse events reported by the participants will be documented and reported.

Secondary Outcome Measures

Global cognition
It will be assessed with the Hong Kong version Montreal of Cognitive Assessment. The total score of the instrument ranges from 0 - 30. Higher score indicates better cognitive functions.
Memory
It will be measured with Fuld Object Memory Evaluation. It consists of three subscores, namely the total storage, total retrieval and delayed recall with the highest possible scores of 50, 50, and 10 respectively. Higher the scores indicate better cognitive functions.
Visual attention and task switching
It will be measured with the Trail Making Test (TMT), which consists of two parts: TMT-A and TMT-B. Shorter the time used indicates better cognitive functions.
Mobility
It will be measured with the Time-up-and-Go test. It represents the total time needed for the participants to stand and walk for 3 meters, turn around and walk back to the chair and sit down. Shorter the time used indicates better monility.
Gait speed
The time used for the 6-meter walk, shorter the time used indicates better gait speed.
Leg strength and endurance
It will be assessed with the Chair Stand Test. The participants will be required to stand up repeatedly from a chair for 30 seconds. The higher number of stands a person can complete in 30 seconds, indicates a better leg strength and endurance.
Physical activity
It will be measured with the Physical Activity Scale for the Elderly, which quantify the amount of daily physical activity. The total score ranges from 0 to 793, with a higher score indicates a larger amount of physical activity.
Hand-grip strength
It will be measured with a handgrip dyanometer.
Strength of upper extremities
It will be measured with the Arm-Curl Test. The number of bicep curls in 30 seconds while holding a hand weight.
Actigraph data
Data will be collected with a wrist worn Actigraph GT3X+ device.
Frailty status
The Fried Frailty Index will be used to measure the frailty status. The total score ranges from 0 to five. Higher score indicates a higher frailty level. Score 0, 1-2, and 3-5 correspond to robust, pre-frail, and frail respectively.

Full Information

First Posted
January 19, 2023
Last Updated
September 25, 2023
Sponsor
The Hong Kong Polytechnic University
Collaborators
Tung Wah College, Hospital Authority, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05750121
Brief Title
E-health Enhanced Motor-cognitive Training for AED Discharged Older Adults With Cognitive Frailty
Official Title
Effects of E-health Enhanced Motor-cognitive Training on Cognitive Functions, Physical Frailty and Physical Functions of Accident and Emergency Department Discharged Community-dwelling Older Adults With Cognitive Frailty: A Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2023 (Actual)
Primary Completion Date
January 29, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Tung Wah College, Hospital Authority, Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this pilot randomized controlled trial is to explore the feasibility of e-health enhanced motor-cognitive interventions for discharged community-dwelling older adults with cognitive frailty in the emergency department and to evaluate the effectiveness of the interventions on (1) cognitive functions, (2) physical functions and (3) frailty status. Participants in the intervention group will receive three-90-minute weekly physical and cognitive training for 12 weeks, facilitated with persuasive technology on smartphones, in addition to the usual care. The control group will receive the usual care. Researchers will explore the feasibility and compare the changes of outcomes between two groups.
Detailed Description
Motor-cognitive training effectively reverses and prevents further deterioration of cognitive function, frailty status, and physical function in older adults with cognitive frailty. Recent systematic reviews showed that older adults with cognitive frailty are more likely to develop dementia and have falls than those with frailty alone. The current time-pressured Accident and Emergency Department (AED) setting is challenging for the practitioners to have an intervention to maintain or improve the current physical and cognitive function of these older adults with non-acute complaints and prone to further deteriorate after being discharged from AED. There is a mismatch of services in traditional emergency medicine with the demand of the elderly population. Particular intervention for these older adults is needed. Based on the systematic review and the previous literature, motor-cognitive training is an essential intervention component. Interventions in a home setting can increase flexibility and improve adherence to the intervention. However, the effect on motor-cognitive training in a home setting is unknown. This study aims to explore the feasibility of e-health enhanced motor-cognitive interventions for discharged community-dwelling older adults with cognitive frailty in the emergency department and to evaluate the effectiveness of the interventions on (1) cognitive functions, (2) physical functions and (3) frailty status. This study is a single-blinded pilot randomised, controlled study. Subjects will be allocated to either the intervention or control group by a 1:1 ratio, where they will receive motor-cognitive training in addition to usual care or usual care only. The program will be targeted older adults aged 60 or above with cognitive frailty and discharged from AED. The intervention lasts for 12 weeks, with three 90 minutes sessions (60 minutes of physical activity and 30 minutes of cognitive training) per week. Trained emergency nurses will provide respective assessments and interventions separately. The primary outcomes are to check the feasibility, including compliance, adherence and adverse effect of the study. Intervention efficacy is the secondary outcome, including physical frailty level, physical performance, and cognitive function. Fried Frailty Index will measure frailty level, physical performance will be measured by Timed-Up-Go Test, handgrip strength, gait speed, chair stand test, arm curl test and Physical Activity Scale for the Elderly. Montreal cognitive assessment (MoCA), Fuld object-memory evaluation (FOME), trail making test (TMT) will be used to measure the cognitive functions. Secondary outcome indicators included. Data will be collected in two-time points, baseline and post-intervention Findings of the study can help in improving the actual research and providing evidence for implementing motor-cognitive training for AED-discharged older adults with cognitive frailty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Mild Cognitive Impairment
Keywords
Cognitive frailty, Motor-Cognitive Training, Older Adults, Discharged

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
Care providers are not included in the study and will not be informed about the group assignment. An independent administrator will allocate the identifier to the participants and randomise the participants into groups. The administrator will not be involved in the analysis, data collection, outcome assessments, and intervention delivery. All assessments were conducted by a registered nurse blinded to grouping allocation and will not be involved in intervention training.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
The intervention group will receive home-based motor-cognitive training and usual emergency care.
Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
Usual care includes wound care, community nurse service, medications and on-site physiotherapy, occupational therapy, community nurse service, medical social work service, and geriatric nurse follow-up service will be referred when necessary.
Intervention Type
Behavioral
Intervention Name(s)
E-health enhanced motor-cognitive training
Intervention Description
The intervention group will implement physical activity (aerobic exercise and resistance training) and cognitive training (CogniFit) intervention with the e-health components (persuasive technology). The intervention period will last for 12 weeks, with three 90 minutes sessions (60 minutes of physical activity and 30 minutes of cognitive training) per week.
Primary Outcome Measure Information:
Title
Recruitment rate
Description
One of the feasibility outcomes. It is the overall recruitment rate, which will be calculated by dividing the number of recruited and randomized, by the total invited eligible potential participants. It will range from 0 to 100%.
Time Frame
At baseline
Title
Retention rate
Description
One of the feasibility outcomes. It is calculated by dividing the number of randomised participants retained and assessed with valid primary outcome data at the end of the project, by the recruited participants. It will range from 0 to 100%.
Time Frame
At the 12th - 14th week (post-intervention)
Title
Adverse events
Description
A feasibility indicators, which is defined as an undesired effect of the intervention. Any adverse events reported by the participants will be documented and reported.
Time Frame
Continuous monitoring throughout the 12 weeks of intervention
Secondary Outcome Measure Information:
Title
Global cognition
Description
It will be assessed with the Hong Kong version Montreal of Cognitive Assessment. The total score of the instrument ranges from 0 - 30. Higher score indicates better cognitive functions.
Time Frame
At baseline, and the 12th - 14th week (post intervention)
Title
Memory
Description
It will be measured with Fuld Object Memory Evaluation. It consists of three subscores, namely the total storage, total retrieval and delayed recall with the highest possible scores of 50, 50, and 10 respectively. Higher the scores indicate better cognitive functions.
Time Frame
At baseline, and the 12th - 14th week (post intervention)
Title
Visual attention and task switching
Description
It will be measured with the Trail Making Test (TMT), which consists of two parts: TMT-A and TMT-B. Shorter the time used indicates better cognitive functions.
Time Frame
At baseline, and the 12th - 14th week (post intervention)
Title
Mobility
Description
It will be measured with the Time-up-and-Go test. It represents the total time needed for the participants to stand and walk for 3 meters, turn around and walk back to the chair and sit down. Shorter the time used indicates better monility.
Time Frame
At baseline, and the 12th - 14th week (post intervention)
Title
Gait speed
Description
The time used for the 6-meter walk, shorter the time used indicates better gait speed.
Time Frame
At baseline, and the 12th - 14th week (post intervention)
Title
Leg strength and endurance
Description
It will be assessed with the Chair Stand Test. The participants will be required to stand up repeatedly from a chair for 30 seconds. The higher number of stands a person can complete in 30 seconds, indicates a better leg strength and endurance.
Time Frame
At baseline, and the 12th - 14th week (post intervention)
Title
Physical activity
Description
It will be measured with the Physical Activity Scale for the Elderly, which quantify the amount of daily physical activity. The total score ranges from 0 to 793, with a higher score indicates a larger amount of physical activity.
Time Frame
At baseline, and the 12th - 14th week (post intervention)
Title
Hand-grip strength
Description
It will be measured with a handgrip dyanometer.
Time Frame
At baseline, and the 12th - 14th week (post intervention)
Title
Strength of upper extremities
Description
It will be measured with the Arm-Curl Test. The number of bicep curls in 30 seconds while holding a hand weight.
Time Frame
At baseline, and the 12th - 14th week (post intervention)
Title
Actigraph data
Description
Data will be collected with a wrist worn Actigraph GT3X+ device.
Time Frame
Throughout the 12 weeks intervention period.
Title
Frailty status
Description
The Fried Frailty Index will be used to measure the frailty status. The total score ranges from 0 to five. Higher score indicates a higher frailty level. Score 0, 1-2, and 3-5 correspond to robust, pre-frail, and frail respectively.
Time Frame
At baseline, and the 12th - 14th week (post intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 60 years old or above; discharged from the AED; Cantonese speaking; have a smartphone and have experience in using the smartphone for at least six months; with cognitive frailty, the coexistence of mild cognitive impairment (MCI) and physical frailty, without being diagnosed as dementia. Exclusion Criteria: unable to make consent, unable to communicate due to language barrier or visual impairment or uncorrectable hearing impairment, old aged home residents, already participated in other interventional studies, participate in any geriatric program and training, or impaired mobility
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daphne Cheung, PhD
Phone
+852 27664534
Email
daphne.cheung@polyu.edu.hk
Facility Information:
Facility Name
School of Nursing, The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daphne Cheung, PhD
Phone
+852 27664534
Email
daphne.cheung@polyu.edu.hk
First Name & Middle Initial & Last Name & Degree
Rick Kwan, PhD
First Name & Middle Initial & Last Name & Degree
Ada Tam, MSc

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

E-health Enhanced Motor-cognitive Training for AED Discharged Older Adults With Cognitive Frailty

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