Impact Evaluation of the Digital Connect Project for Homebound Older Adults

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aging Well
• Intervention / Treatment: Behavioral: Digital intervention through Tablet

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 Type: Interventional
• Enrollment (Estimated): 1024
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Doris Sau Fung YU, PhD; Phone Number: 852 3917 6319; Email: dyu1@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The University of Hong Kong
    • Contact: Doris Sau Fung Yu, PhD; Phone Number: 3917 6319; Email: dyu1@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment status; 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.	Behavioral: Digital intervention through Tablet; 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.
Placebo Comparator: No-treatment status; 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.	Behavioral: Digital intervention through Tablet; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life (HRQL)	Measure by EQ-5D-5L (range from -0.59 to 1.0), higher score indicates better quality of life	Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
Physical function	Measured by Short Physical Performance Battery (range from 0 to 12), with higher score indicating better physical performance	Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
Cognitive function score	Measured by 5-minute Montreal Cognitive Assessment (MoCA) (range from 0 to 30), A score of 26 or over is considered to be normal.	Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
Subjective Memory Score	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).	Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
Loneliness score	Measured by 3-item UCLA Loneliness Scale (range 3-9), higher score indicates greater loneliness.	Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
Depression score	Measured by The 8-item Geriatric Depression Scale (range 0 to 8), with higher score indicating higher risk of depression	Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
Social function	Measured by 8-item Social Connectedness Scale Revised (range 0 to 48), <22 indicates lack of social connectedness	Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Doris Sau Fung YU, PhD, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Ageing; Digital intervention; Functional capacity
• Other Study ID Numbers: Digital Connect

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No