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

NCT ID: NCT06785857

Last Updated: 2025-12-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Senile Dementia, Alzheimer Type

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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an offline supportive care program

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.

Group Type ACTIVE_COMPARATOR

Offline supportive care

Intervention Type 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.

mHealth Supportive Care Program

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.

Group Type EXPERIMENTAL

mHealth Supportive Care Program

Intervention Type 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.

Interventions

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mHealth Supportive Care Program

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.

Intervention Type OTHER

Offline supportive care

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yuanjiao Yan

OTHER

Sponsor Role lead

Responsible Party

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Yuanjiao Yan

Sponsor-Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Community Health Center

Xiamen, Fujian, China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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K2021-05-024

Identifier Type: -

Identifier Source: org_study_id