A Study of Mobile Medical Supportive Care Program for Family Caregivers With Dementia Combined With Diabetes

NCT06785857 | Completed Results DMC

• 1 other identifier: K2021-05-024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to evaluate the effectiveness of the clinical application of a mHealth supportive care program for family caregivers with dementia combined with diabetes based on the supportive care framework. The results of the study will provide family caregivers with more economical and efficient care guidance, thereby improving the quality of care and quality of life for people with dementia and diabetes in general.

Conditions

Diabetes; Senile Dementia, Alzheimer Type

Keywords

Dementia; Diabetes; Family caregivers; Mobile healthcare; Supportive care programs; A randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Caregiver Burden Inventory- Baseline (Month 0)

  The scale used in this study was obtained by Rui Zhang based on the Chinese version of the CBI by Taiwanese scholar Guiru Zhou, who modified the questionnaire according to the linguistic characteristics of mainland China.The CBI was initially used to measure the evaluation of the burden on caregivers of patients with dementia, which includes multiple dimensions such as physical burden, emotional burden, social burden, time-dependent burden, and developmentally limited burden, and the scoring of each entry was based on a Likert 5-point scale ranging from strongly agree (4) to strongly disagree (0). Likert 5-point scale from strongly agree (4 points) to strongly disagree (0 points). Total scale scores ranged from 0 to 96; higher scores indicated greater caregiver burden. When the score is ≥ 24, consideration should be given to receiving therapeutic interventions; when the score is greater than or equal to 36, it suggests the risk of severe burden.

  Baseline (pre-intervention)

• Caregiver Burden Inventory - Post-intervention (Month 3)

  The scale used in this study was obtained by Rui Zhang based on the Chinese version of the CBI by Taiwanese scholar Guiru Zhou, who modified the questionnaire according to the linguistic characteristics of mainland China.The CBI was initially used to measure the evaluation of the burden on caregivers of patients with dementia, which includes multiple dimensions such as physical burden, emotional burden, social burden, time-dependent burden, and developmentally limited burden, and the scoring of each entry was based on a Likert 5-point scale ranging from strongly agree (4) to strongly disagree (0). Likert 5-point scale from strongly agree (4 points) to strongly disagree (0 points). Total scale scores ranged from 0 to 96; higher scores indicated greater caregiver burden. When the score is ≥ 24, consideration should be given to receiving therapeutic interventions; when the score is greater than or equal to 36, it suggests the risk of severe burden.

  Post-intervention (Month 3)

Secondary Outcomes (4)

• Social Support Rating Scale - Post-intervention (Month 3)

  Post-intervention (Month 3)

• Dementia Caring Knowledge Scale - Post-intervention (Month 3)

  Post-intervention (Month 3)

• Social Support Rating Scale - Baseline (Month 0)

  Baseline (Pre-intervention)

• Dementia Caring Knowledge Scale-Baseline (Month 0)

  Baseline (Pre-intervention)

Study Arms (2)

an offline supportive care program

ACTIVE COMPARATOR

This was done routinely in accordance with the requirements of public health services for chronic diseases in the community elderly. In addition, health education on diabetes mellitus and dementia was provided to the caregivers during their monthly home visits. ① the content of diabetes health education: the researcher gave the caregivers education and training on the care of diabetes patients: the main points of care in diet, sleep, exercise, etc. ② The content of dementia health education: the researcher gave the caregivers education and training related to the care of dementia patients: instructing the caregivers in the basic life care skills of patients' diet, sleep, exercise, etc.

Other: Offline supportive care

mHealth Supportive Care Program

EXPERIMENTAL

On the basis of the monthly home visits in the control group, "Xiamen iHealth" was used as a medium to add a weekly mHealth supportive care intervention program, with one supportive care item every two weeks for 12 weeks, for a total of 12 online interventions, as well as to provide online consultation and appointment services for caregivers at any time.

Other: mHealth Supportive Care Program

Interventions

Offline supportive care OTHER

This was done routinely in accordance with the requirements of public health services for chronic diseases in the community elderly. In addition, health education on diabetes mellitus and dementia was provided to the caregivers during their monthly home visits. ① the content of diabetes health education: the researcher gave the caregivers education and training on the care of diabetes patients: the main points of care in diet, sleep, exercise, etc. ② The content of dementia health education: the researcher gave the caregivers education and training related to the care of dementia patients: instructing the caregivers in the basic life care skills of patients' diet, sleep, exercise, etc.

an offline supportive care program

mHealth Supportive Care Program OTHER

On the basis of monthly home visits in the control group, a weekly mHealth supportive care intervention program was added through the medium of Xiamen iHealth, with one supportive care item every two weeks for 12 weeks, for a total of 12 online interventions, as well as the provision of online consulting and booking services for caregivers at any time.

mHealth Supportive Care Program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Caregivers:
• caregivers and patients have legal kinship (such as spouses, children or siblings) and other non-costly caregivers such as babysitters, bellhops, etc.;
• caregiving work ≥ 8 hours / day, care for the patient ≥ 5 days a week, the care time ≥ 1 month;
• conscious adults with a certain degree of reading and comprehension;
• at least have a smart phone (with Internet access) and will be able to use it proficiently;
• informed consent and voluntary participation in the study. Informed consent and voluntary participation in the study.
• Targets:
• meet the diagnostic criteria of Alzheimer's disease;
• meet the diagnostic criteria of type 2 diabetes mellitus;
• age ≥ 60 years old, permanent residents of the district.

You may not qualify if:

• Caregivers:
• severe physical or mental illness;
• people with drug or alcohol dependence;
• caregivers who are participating in a similar intervention study.
• Caregivers:
• patients with severe physical illnesses, major illnesses, or terminal illnesses;
• patients with drug or alcohol dependence.

Sponsors & Collaborators

• Yuanjiao Yan: lead

Study Sites (1)

Community Health Center

Xiamen, Fujian, 361000, China

Location

MeSH Terms

Conditions

Diabetes Mellitus; Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Miaoqian Huang
• Organization: Xiamen Tongan District Xiangping Street Community Health Service Center

hmiaoqian@163.com

15880248915

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The intervention group received an mHealth supportive care program, the control group received an offline supportive care program, and all caregivers received health education related to diabetes and dementia. The intervention was conducted concurrently in the experimental and control groups, and both groups were followed up in the home once a month for 12 weeks, with each caregiver receiving three 1-hour visits from the researcher.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 21, 2025
• Study Start: May 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: January 1, 2023
• Last Updated: December 16, 2025
• Results First Posted: December 16, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: After completion of the study,relevant data will be provided in the form of a URL or DOI.
• Access Criteria: Researchers whose proposed use of the data has been approved.

Locations

CN (1)