Impact Evaluation of the Digital Connect Project for Homebound Older Adults

Aging Well Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06217601
• Other study ID #: Digital Connect
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: January 2024
• Source: The University of Hong Kong
• Contact: Doris Sau Fung YU, PhD
• Phone: 852 3917 6319
• Email: dyu1[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1024
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Aging Well

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.