Aging WellNCT06217601
Impact Evaluation of the Digital Connect Project for Homebound Older Adults
A study testing Digital intervention through Tablet in people with Aging Well, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging Well
- What is being tested?
- Digital intervention through Tablet
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,024 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2023to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Aging Well
- Being tested
- Digital intervention through Tablet
- Keywords
- Ageing, Digital intervention, Functional capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital intervention through TabletBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Digital intervention through Tablet |
| 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. Receives: Behavioral: Digital intervention through Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Jun 2023
- Primary completion30 Jun 2026
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging WellStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,024 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Yu, Doris Sau Fung, The University of Hong Kong
- Investigators
- Doris Sau Fung YU, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217601
- Sponsor's protocol ID
- Digital Connect
- Status last verified
- Jul 2026
- First submitted
- 8 Jan 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Evaluation of the Digital Connect Project for Homebound Older Adults: A Target Trial Emulation
- ClinicalTrials.gov ID
- NCT06217601
- Acronym / sponsor ID
- Digital Connect
- Conditions
- Aging Well
- Keywords
- Ageing, Digital intervention, Functional capacity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,024 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment status | Experimental | Behavioral: Digital intervention through TabletTo 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. |
| No-treatment status | Placebo comparator | Behavioral: Digital intervention through TabletTo 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital intervention through TabletWeb-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. | Behavioural | No-treatment status, Treatment status |
Primary outcome
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
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.
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).
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data (IPD) available to other researchers.
Related trials for Aging Well
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
Recruiting
Study Evaluating the Effect of Humiome® Post LB on Stress, Anxiety, and Cognition in Aging Adults
Healthy Aging
Recruiting
Effects of Breathing Exercises on Cognition in Older Adults
Older Adults (65 Years and Older), Cognition
Not yet recruiting
Eccentric Exercise in Community-dwelling Older Adults
Ageing Well
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doris Sau Fung YU, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital intervention through Tablet in people with Aging Well, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (HRQL) (time frame: Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.