Skip to main content
Clinical Trials/NCT06217601
NCT06217601Active, not recruitingNot Applicable

Impact Evaluation of the Digital Connect Project for Homebound Older Adults: A Target Trial Emulation

The University of Hong Kong1 site in 1 country1,024 target enrollmentStarted: June 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
1,024
Locations
1
Primary Endpoint
Cognitive function score

Study Overview

Brief Summary

The goal of this study is to evaluate the impact of the Digital Connect Project on increasing functional capacity defined by the WHO-ICOPE and health-related quality of life (HRQL) among homebound older adults.

Detailed Description

The Hong Kong Jockey Club Charities Trust is launching the Digital Connect project to increase the well-being and social connectedness of the homebound older adults. A total of 32 NGOs are applying for 7,500 tablets and data plan (in total) through this project. Different digital programs will be rolled out to enhance their well-being and social connectedness. This study aim is to capture the impact of this Digital Connect project on the health outcomes of the homebound older adults. The tablet intervention will be offered by the NGOs within a 2-year timeframe. Web-based multi-domain lifestyle training intervention will be conducted to promoted and focus three lifestyles: nutritional advice, exercise and cognitive training; chat communication with research team, and personalized agenda on daily activities and an information library.

The object of this study is to explore the dose-response relationship between online engagement in the different types of activity and the improvement in the corresponding health outcomes, including the five domains: (1) Physical function, (2) Cognitive function, (3) Psychological function, (4) Social function and (5) Health-related quality of life. One baseline assessment and four follow-ups will be arranged in every 3-month interval. To account for immortal time bias, each subject will be created with two clones at time zero and assigned each of the two clones to either treatment or control group, respectively.

The engagement experience will be explored by interviewing the participants and service stakeholders through the planning and delivery of the digital intervention for the homebound older adults.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •age > 65
  • •consent to participate
  • •able to participate in the impact assessment as evidence by a test score of > 6 on the Abbreviated Mental Test
  • •has the functional ability to engage in the digital intervention

Exclusion Criteria

  • Not provided

Arms & Interventions

Treatment status

Experimental

To account for immortal time bias, each subject will be created with two clones at time zero and assigned each of the two clones to either treatment or no-treatment status, respectively. The treatment status in each evaluative endpoint (i.e., 3-month, 6-month, and 12-month) is defined as subjects who have received the digital intervention for the respective length of time since the time zero during which the intervention has just commenced.

Intervention: Digital intervention through Tablet (Behavioral)

No-treatment status

Placebo Comparator

To account for immortal time bias, each subject will be created with two clones at time zero and assigned each of the two clones to either treatment or no-treatment status, respectively. The corresponding no-treatment status is defined as subjects who have not received the digital intervention for the corresponding length of time.

Intervention: Digital intervention through Tablet (Behavioral)

Outcomes

Primary Outcomes

Cognitive function score

Time Frame: Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.

Measured by 5-minute Montreal Cognitive Assessment (MoCA) (range from 0 to 30), A score of 26 or over is considered to be normal.

Health-related quality of life (HRQL)

Time Frame: Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.

Measure by EQ-5D-5L (range from -0.59 to 1.0), higher score indicates better quality of life

Physical function

Time Frame: Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.

Measured by Short Physical Performance Battery (range from 0 to 12), with higher score indicating better physical performance

Loneliness score

Time Frame: Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.

Measured by 3-item UCLA Loneliness Scale (range 3-9), higher score indicates greater loneliness.

Depression score

Time Frame: Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.

Measured by The 8-item Geriatric Depression Scale (range 0 to 8), with higher score indicating higher risk of depression

Social function

Time Frame: Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.

Measured by 8-item Social Connectedness Scale Revised (range 0 to 48), \<22 indicates lack of social connectedness

Subjective Memory Score

Time Frame: Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.

Measured by 7-item Memory Complaint Scale (MCS) (range from 0 to 14), lower score indicates better memory performance. No MCs (0-2), Mild MCs (3-6), Moderate MCs (7-10), Severe MCs (11-14).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof. Yu, Doris Sau Fung

Professor

The University of Hong Kong

Study Sites (1)

Loading locations...

Similar Trials

Impact Evaluation of the Digital Connect... | Clinical Trial