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

NCT05750121 | Unknown DMC

• 1 other identifier: HSEARS20220307001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Mild Cognitive Impairment

Keywords

Cognitive frailty; Motor-Cognitive Training; Older Adults; Discharged

Outcome Measures

Primary Outcomes (3)

• 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%.

  At baseline

• 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%.

  At the 12th - 14th week (post-intervention)

• 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.

  Continuous monitoring throughout the 12 weeks of intervention

Secondary Outcomes (11)

• Global cognition

  At baseline, and the 12th - 14th week (post intervention)

• Memory

  At baseline, and the 12th - 14th week (post intervention)

• Visual attention and task switching

  At baseline, and the 12th - 14th week (post intervention)

• Mobility

  At baseline, and the 12th - 14th week (post intervention)

• Gait speed

  At baseline, and the 12th - 14th week (post intervention)

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Behavioral: E-health enhanced motor-cognitive training

Usual care group

NO INTERVENTION

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.

Interventions

E-health enhanced motor-cognitive training BEHAVIORAL

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.

Treatment group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Tung Wah College: collaborator
• Hospital Authority, Hong Kong: collaborator

Study Sites (1)

School of Nursing, The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Frailty; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Daphne Cheung, PhD

CONTACT

+852 27664534; daphne.cheung@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 1. Care providers are not included in the study and will not be informed about the group assignment. 2. 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. 3. All assessments were conducted by a registered nurse blinded to grouping allocation and will not be involved in intervention training.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: March 1, 2023
• Study Start: March 23, 2023
• Primary Completion: January 29, 2024
• Study Completion: January 1, 2025
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

HK (1)