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

Not Applicable

Completed

• Conditions: Diabetes; Senile Dementia, Alzheimer Type

• Registration Number: NCT06785857
• Lead Sponsor: Yuanjiao Yan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-01
• Primary Completion: 2022-09-01
• Study Completion: 2023-01-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-15
• Last Update Submitted: 2025-01-15
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Caregivers: ① caregivers and patients have legal kinship (such as spouses, children or siblings) and other non-costly caregivers such as babysitters, bellhops, etc.; ② caregiving work ≥ 8 hours / day, care for the patient ≥ 5 days a week, the care time ≥ 1 month; ③ conscious adults with a certain degree of reading and comprehension; ④ at least have a smart phone (with Internet access) and will be able to use it proficiently; ⑤ informed consent and voluntary participation in the study. Informed consent and voluntary participation in the study.

Targets: ① meet the diagnostic criteria of Alzheimer's disease; ② meet the diagnostic criteria of type 2 diabetes mellitus; ③ age ≥ 60 years old, permanent residents of the district.

Exclusion Criteria

Caregivers: ① severe physical or mental illness; ② people with drug or alcohol dependence; ③ caregivers who are participating in a similar intervention study.

Caregivers: ① patients with severe physical illnesses, major illnesses, or terminal illnesses; ② patients with drug or alcohol dependence.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Caregiver Burden Inventory	First and third months	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.

Secondary Outcome Measures

Name	Time	Method
Social Support Rating Scale	First and third months	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. Objective support score: the sum of 2, 4, and 6 scores; subjective support score: the sum of 1, 3, 4, and 5 scores; utilization of support: the sum of 8, 9, and 10 scores; Purpose: to detect the degree of psychological support received by the individual in the social life, and the utilization of support. Judgment criteria: the total score of the scale is 40 points, the higher the score, the higher the degree of social support, it is generally believed that the total score is less than 20, the degree of social support is less, 20-30 has a general degree of social support, and 30-40 has a satisfactory degree of 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.
Dementia Caring Knowledge Scale	First and third months	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.

Trial Locations

Locations (1)

Community Health Center; 🇨🇳 Xiamen, Fujian, China