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

NCT ID: NCT05750121

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-23

Study Completion Date

2025-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Frailty Mild Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment group

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

Group Type EXPERIMENTAL

E-health enhanced motor-cognitive training

Intervention Type 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.

Usual care group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

E-health enhanced motor-cognitive training

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tung Wah College

OTHER

Sponsor Role collaborator

Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Daphne Cheung

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

School of Nursing, The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Daphne Cheung, PhD

Role: CONTACT

+852 27664534

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Daphne Cheung, PhD

Role: primary

+852 27664534

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HSEARS20220307001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.