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Clinical Trials/NCT05750121
NCT05750121
Recruiting
Not Applicable

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

The Hong Kong Polytechnic University1 site in 1 country40 target enrollmentMarch 23, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Frailty
Sponsor
The Hong Kong Polytechnic University
Enrollment
40
Locations
1
Primary Endpoint
Recruitment rate
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 23, 2023
End Date
January 1, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr Daphne Cheung

Associate Professor

The Hong Kong Polytechnic University

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

Outcomes

Primary Outcomes

Recruitment rate

Time Frame: At baseline

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%.

Adverse events

Time Frame: Continuous monitoring throughout the 12 weeks of intervention

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.

Retention rate

Time Frame: At the 12th - 14th week (post-intervention)

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%.

Secondary Outcomes

  • Actigraph data(Throughout the 12 weeks intervention period.)
  • Global cognition(At baseline, and the 12th - 14th week (post intervention))
  • Visual attention and task switching(At baseline, and the 12th - 14th week (post intervention))
  • Physical activity(At baseline, and the 12th - 14th week (post intervention))
  • Hand-grip strength(At baseline, and the 12th - 14th week (post intervention))
  • Memory(At baseline, and the 12th - 14th week (post intervention))
  • Gait speed(At baseline, and the 12th - 14th week (post intervention))
  • Leg strength and endurance(At baseline, and the 12th - 14th week (post intervention))
  • Frailty status(At baseline, and the 12th - 14th week (post intervention))
  • Mobility(At baseline, and the 12th - 14th week (post intervention))
  • Strength of upper extremities(At baseline, and the 12th - 14th week (post intervention))

Study Sites (1)

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