DiabetesNCT06785857
A Study of Mobile Medical Supportive Care Program for Family Caregivers With Dementia Combined With Diabetes
A study testing mHealth Supportive Care Program and Offline supportive care in people with Diabetes and Senile Dementia, Alzheimer Type, run by Yuanjiao Yan at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Senile Dementia, Alzheimer Type
- What is being tested?
- mHealth Supportive Care Program and Offline supportive care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Diabetes, Senile Dementia, Alzheimer Type
- Being tested
- mHealth Supportive Care Program, Offline supportive care
- Keywords
- Dementia, Diabetes, Family caregivers, Mobile healthcare, Supportive care programs, A randomized controlled trial
- Medical subject headings
- Diabetes Mellitus, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth Supportive Care ProgramOther
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.
Offline supportive careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: mHealth Supportive Care Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Post-intervention (Month 3)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Pre-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start1 May 2022
- Primary completion1 Sep 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuanjiao Yan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuanjiao Yan, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785857
- Sponsor's protocol ID
- K2021-05-024
- Status last verified
- Nov 2025
- First submitted
- 15 Jan 2025
- Last updated
- 16 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention Effect Study of a Mobile Medical Supportive Care Program for Family Caregivers With Dementia Combined With Diabetes: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06785857
- Acronym / sponsor ID
- K2021-05-024
- Conditions
- Diabetes, Senile Dementia, Alzheimer Type
- Keywords
- Dementia, Diabetes, Family caregivers, Mobile healthcare, Supportive care programs, A randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yuanjiao YanUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 21 Jan 2025 (actual)
- Results
- Posted 16 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| an offline supportive care program | Active comparator | Other: Offline supportive careThis 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 | Experimental | Other: mHealth Supportive Care ProgramOn 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- severe physical or mental illness;
- people with drug or alcohol dependence;
- caregivers who are participating in a similar intervention study.
- patients with severe physical illnesses, major illnesses, or terminal illnesses;
- patients with drug or alcohol dependence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth Supportive Care ProgramOn 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. | Other | mHealth Supportive Care Program |
| Offline supportive careThis 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 | an offline supportive care program |
Primary outcome
Caregiver Burden Inventory- Baseline (Month 0)
Time frame: Baseline (pre-intervention)
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.
Caregiver Burden Inventory - Post-intervention (Month 3)
Time frame: 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.
4 secondary outcomes
Social Support Rating Scale - Post-intervention (Month 3)
Time frame: Post-intervention (Month 3)
Dementia Caring Knowledge Scale - Post-intervention (Month 3)
Time frame: Post-intervention (Month 3)
Social Support Rating Scale - Baseline (Month 0)
Time frame: Baseline (Pre-intervention)
Dementia Caring Knowledge Scale-Baseline (Month 0)
Time frame: Baseline (Pre-intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth Supportive Care Program and Offline supportive care in people with Diabetes and Senile Dementia, Alzheimer Type, run by Yuanjiao Yan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Burden Inventory- Baseline (Month 0) (time frame: Baseline (pre-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.