Clinical trial NCT06217601: Impact Evaluation of the Digital Connect Project for Homebound Older Adults
Official title: Impact Evaluation of the Digital Connect Project for Homebound Older Adults: a Target Trial Emulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging Well
Keywords: Ageing
Digital intervention
Functional capacity
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 1024
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Health-related quality of life (HRQL)
timeFrame: Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
measure: Physical function
timeFrame: Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
measure: Cognitive function score
timeFrame: Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
measure: Subjective Memory Score
timeFrame: Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
measure: Loneliness score
timeFrame: Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
measure: Depression score
timeFrame: Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
measure: Social function
timeFrame: Changes from baseline to 3 month, 6 month, 9 month, and 12 month post-intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Doris Sau Fung YU, PhD
role: PRINCIPAL_INVESTIGATOR
References: