Longitudinal Effectiveness of HEART Smartphone- Based Videoconferencing Program in Enhancing Residents and Family'Health

August 15, 2024 updated by: Chang Gung Memorial Hospital

The Longitudinal Effectiveness of Helper of Emotional Assessment and Relationship Teaching (HEART) Smartphone- Based Videoconferencing Program in Enhancing Residents and Their Family' Health

This study intends to understand the longitudinal effectiveness of the smartphone- based Helper of Emotional Assessment ＆Relationship Teaching (HEART) videoconferencing program in enhancing residents and family health through the employment of a sequential-methods, triangulation research design.

In the phase I lasing 18 months, it will employ: (a) a web-based RT/communication education programs which is develop based on understanding the experience of videoconferencing visit from family in nursing home, and (b) a HEA system which is for real-time face emotion recognition system used in videoconferencing will be developed and tested. In the phase II occupying the second 18 months it will evaluate the longitudinal effects of the HEART program on residents' and family's health change over time (baseline, 1 month, 3 months, and 6 months).

Nursing homes in Taiwan will be automated computerized blocked randomly assigned to three groups: (a) An RT group, which receives the RT program and uses 3 months' smartphone-based videoconferencing without the HEA system, (b) A HEART group, which receives the RT program and uses 3 months smartphone-based videoconferencing along with the HEA system, and(c) A control group, which has only smartphone-based videoconferencing visits.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Hsinchu, Taiwan
        • Catholic Mercy Hospital Attached Nursing Home

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. residents were aged equal or higher than 60 years, resident's family were aged equal or higher than 20 years.
  2. both residents and family could communicate in Mandarin or Taiwanese
  3. both residents and family have no serious hearing problems
  4. residents has a MMSE score equal or higher than 16 for residents with no formal education or higher than 24 for residents with at least a primary school education
  5. both residents and family agree to participate,
  6. family is the significant member of residents, such as caregivers.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RT group
receives the RT program and uses 3 months' smartphone-based videoconferencing without the HEA system
Behavioral: a web-based Relationship Teaching(RT)/communication education programs
receives the RT program and uses 3 months' smartphone-based videoconferencing without the HEA system.
Experimental: HEART group
receives the RT program and uses 3 months smartphone-based videoconferencing along with the HEA system
Behavioral: Helper of Emotional Assessment Relationship Teaching (HEART) program
receives the RT program and uses 3 months smartphone-based videoconferencing along with the HEA system
No Intervention: control group
which has only smartphone-based videoconferencing visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
family's communication knowledge
Time Frame: baseline, 1 month, 3 months and 6 months
on-line test (questionnaire scored from 0 through to 100. Higher scores mean better outcome)
baseline, 1 month, 3 months and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
resident health-heart rate variation (HRV)
Time Frame: baseline, 1 month, 3 months and 6 months
measurement of the variation in time between each heartbeat
baseline, 1 month, 3 months and 6 months
resident health-Geriatric Depression Scale (GDS)
Time Frame: baseline, 1 month, 3 months and 6 months
scale for depression( scored from 0 through to 15.Scores of 0-4 are considered normal; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.)
baseline, 1 month, 3 months and 6 months
resident health-Activity of daily living (ADL)
Time Frame: baseline, 1 month, 3 months and 6 months
assess individual's ability to perform basic self-care tasks ( (scored from 0 through to 100. higher scores mean more independence)
baseline, 1 month, 3 months and 6 months
resident health-profile of mood states(POMS)
Time Frame: baseline, 1 month, 3 months and 6 months
scale for mood states.(scored from 0 through to 232. A lower score describing better mood state)
baseline, 1 month, 3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Study Chair: Hsiu Hsin Tsai, PhD, Chang Gung University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2021

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

May 24, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2024

Last Update Submitted That Met QC Criteria

August 15, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 202100609B0A3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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