NCT04304989

Brief Summary

Homebound older adults are among the highest users in health care systems. The high use of health care services is related to their physical limitations compounded by complex health and social care needs. Homebound older adults can be difficult to reach because they seldom participate and engage in community services due to their functional limitations, which leaves their health needs largely unrecognized at an earlier stage. This study tries to bring this group of older adults to the providers' attention and design a health-social oriented self-care mHealth program and subject it to empirical testing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

May 21, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2020

Completed
Last Updated

December 23, 2020

Status Verified

December 1, 2020

Enrollment Period

2 months

First QC Date

March 8, 2020

Last Update Submit

December 21, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-efficacy will be measured by general self-efficacy scale

    measured by the general self-efficacy scale. The score is from 10-40, higher the better.

    Change from Baseline score of general self-efficacy scale at 3 months

Secondary Outcomes (8)

  • instrumental activity of daily living

    Change from Baseline score of Lawton Instrumental activity of daily living scale at 3 months

  • medication adherence

    Change from Baseline score of adherence to refills and mediaction scale at 3 months

  • Activity of daily living will be measured by Barthel index scale

    Change from Baseline score of Barthel index at 3 months.

  • depression

    Change from Baseline score of geriatric depression scale at 3 months

  • Health service utilisation

    Change from Baseline attendance at 3 months

  • +3 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

This group of participants will receive a video-based mHealth program which includes two main elements: 1) nurse case management supported by a social service team, 2) individual-specific video messages covering self-care topics delivered via smartphone

Other: mHealth program

Control

OTHER

The participants in this group will receive usual care

Other: usual care

Interventions

mobile health applications

Intervention

usual care

Control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • people who are aged 60 or above
  • go outdoor less than once per week in current 6 months
  • living within the service area of community centre
  • using smartphone

You may not qualify if:

  • diagnosed with dementia
  • unable to hear, see or communicate
  • bed-bound
  • active psychiatric illness with recent hospital admission within last 6 months
  • living within an area with no internet coverage
  • already engaged in other mHealth programs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Lutheran Group of social service

Hong Kong, Siu Sai Wan, 00000, Hong Kong

Location

Related Publications (1)

  • Wong AKC, Wong FKY, Chow KKS, Wong SM, Lee PH. Effect of a Telecare Case Management Program for Older Adults Who Are Homebound During the COVID-19 Pandemic: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2021 Sep 1;4(9):e2123453. doi: 10.1001/jamanetworkopen.2021.23453.

Study Officials

  • Arkers Wong

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 8, 2020

First Posted

March 12, 2020

Study Start

May 21, 2020

Primary Completion

July 20, 2020

Study Completion

October 20, 2020

Last Updated

December 23, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations