Impact Evaluation of the Digital Connect Project for Homebound Older Adults

NCT06217601 | Active Not Recruiting

• 1 other identifier: Digital Connect
• Study Type: interventional
• Target: 1,024
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging Well

Keywords

Ageing; Digital intervention; Functional capacity

Outcome Measures

Primary Outcomes (7)

• 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.

Study Arms (2)

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.

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.

Behavioral: Digital intervention through Tablet

Interventions

Digital intervention through Tablet BEHAVIORAL

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.

No-treatment status; Treatment status

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

Study Officials

• Doris Sau Fung YU, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 22, 2024
• Study Start: June 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)