Impact Evaluation of the Digital Connect Project for Homebound Older Adults

March 31, 2026 updated by: Prof. Yu, Doris Sau Fung, The University of Hong Kong

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1024

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Doris Sau Fung YU, PhD
  • Phone Number: 852 3917 6319
  • Email: dyu1@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
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
Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
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.
Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
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).
Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
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.
Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
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
Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
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
Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Doris Sau Fung YU, PhD, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Digital Connect

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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