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

An Intervention Effect Study of a Mobile Medical Supportive Care Program for Family Caregivers With Dementia Combined With Diabetes: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Senile Dementia, Alzheimer Type
• Intervention / Treatment: Other: Offline supportive care; Other: mHealth Supportive Care Program

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361000
      • Community Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Support Rating Scale - Post-intervention (Month 3)	The Social Support Scale was developed by Xiao Shuiyuan, a Chinese scholar, based on China's national conditions, and contains a total of 10 scores. This scale aims to detect the degree of psychological support received by the individual in the social life, and the utilization of support. The total score ranges from 12 to 48. Higher scores indicate higher levels of social support. Generally, scores below 20 indicate low social support, 20-30 indicate moderate social support, and 30-40 indicate satisfactory social support. The re-test reliability of the scale is 0.92, and the consistency of the items is between 0.89 and 0.94; the Cronbach's alpha coefficient is 0.89.	Post-intervention (Month 3)
Dementia Caring Knowledge Scale - Post-intervention (Month 3)	The Dementia Caregiver Knowledge Assessment Scale (DKAS) is based on Maslow's Hierarchy of Needs as a theoretical framework, with "yes", "no", or "don't know" answers for each item. Personal hygiene, diet, excretion, sleep, disease and rehabilitation, medication, safety of the environment and travel, social intimacy, self-esteem, self-realization, etc.; quantitative scoring method, 1 point for a correct answer, 0 points for an incorrect answer or "don't know"; the total score of the scale is 22 points, and the higher the score, the higher the knowledge of dementia caregivers about dementia care. The total score of the scale was 22 points, and the higher the score, the higher the caregiver's knowledge of dementia care; the Cronbach's alpha coefficient of the total scale was 0.626, and the content validity of the scale ranged from 0.86 to 1, with an average CVI of 0.95.	Post-intervention (Month 3)
Social Support Rating Scale - Baseline (Month 0)	The Social Support Scale was developed by Xiao Shuiyuan, a Chinese scholar, based on China's national conditions, and contains a total of 10 scores. This scale aims to detect the degree of psychological support received by the individual in the social life, and the utilization of support. The total score ranges from 12 to 48. Higher scores indicate higher levels of social support. Generally, scores below 20 indicate low social support, 20-30 indicate moderate social support, and 30-40 indicate satisfactory social support. The re-test reliability of the scale is 0.92, and the consistency of the items is between 0.89 and 0.94; the Cronbach's alpha coefficient is 0.89.	Baseline (Pre-intervention)
Dementia Caring Knowledge Scale-Baseline (Month 0)	The Dementia Caregiver Knowledge Assessment Scale (DKAS) is based on Maslow's Hierarchy of Needs as a theoretical framework, with "yes", "no", or "don't know" answers for each item. Personal hygiene, diet, excretion, sleep, disease and rehabilitation, medication, safety of the environment and travel, social intimacy, self-esteem, self-realization, etc.; quantitative scoring method, 1 point for a correct answer, 0 points for an incorrect answer or "don't know"; the total score of the scale is 22 points, and the higher the score, the higher the knowledge of dementia caregivers about dementia care. The total score of the scale was 22 points, and the higher the score, the higher the caregiver's knowledge of dementia care; the Cronbach's alpha coefficient of the total scale was 0.626, and the content validity of the scale ranged from 0.86 to 1, with an average CVI of 0.95.	Baseline (Pre-intervention)

Collaborators and Investigators

• Sponsor: Yuanjiao Yan

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): January 21, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: November 30, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes; Dementia; Family caregivers; A randomized controlled trial; Mobile healthcare; Supportive care programs
• Additional Relevant MeSH Terms: Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Metabolic Diseases; Neurocognitive Disorders; Glucose Metabolism Disorders; Tauopathies; Neurodegenerative Diseases; Nutritional and Metabolic Diseases; Alzheimer Disease; Diabetes Mellitus; Dementia
• Other Study ID Numbers: K2021-05-024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Research data and research-related materials will be available in a repository or online. After completion of the study, relevant data will be provided in the form of a URL or DOI.
• IPD Sharing Time Frame: After completion of the study,relevant data will be provided in the form of a URL or DOI.
• IPD Sharing Access Criteria: Researchers whose proposed use of the data has been approved.
• IPD Sharing Supporting Information Type: SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No