Diabetes, Senile Dementia, Alzheimer Type
Conditions
Keywords
Dementia, Diabetes, Family caregivers, Mobile healthcare, Supportive care programs, A randomized controlled trial
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.
Interventions
OTHERmHealth 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.
OTHEROffline 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.
Sponsors
Yuanjiao Yan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Burden Inventory- Baseline (Month 0) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Social Support Rating Scale - Post-intervention (Month 3) | 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. |
| Dementia Caring Knowledge Scale - Post-intervention (Month 3) | 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. |
| Social Support Rating Scale - Baseline (Month 0) | Baseline (Pre-intervention) | 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. |
| Dementia Caring Knowledge Scale-Baseline (Month 0) | Baseline (Pre-intervention) | 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. |
Countries
China
Participant flow
Recruitment details
This study enrolls family caregivers of elderly patients with both dementia and type 2 diabetes. The patients themselves are not active participants in the study. Their diagnostic criteria (e.g., dementia, diabetes, age ≥60) are solely used to define eligibility for their caregivers. All study procedures (interventions, data collection, and outcome measures) are directed at caregivers only. Patients do not receive interventions or undergo study assessments.
Pre-assignment details
The total enrollment number (N=60) refers to individual caregivers (not patient-caregiver dyads). Collected only for caregivers (e.g., demographics, Caregiver Burden Inventory \[CBI\], Social Support Rating Scale \[SSRS\]). Patient data (e.g., diagnosis confirmation) were used only for screening. All outcomes (e.g., caregiver burden, knowledge, social support) are caregiver-centered. No patient health outcomes are measured.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 27 |
| 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.
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. | 28 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death of the Care recipient (Patients with Dementia and TDM2) | 2 | 3 |
Baseline characteristics
| Characteristic | mHealth Supportive Care Program | an Offline Supportive Care Program | Total |
|---|---|---|---|
| Age, Customized Age (years) <60 | 16 Participants | 11 Participants | 27 Participants |
| Age, Customized Age (years) ≥ 60 | 12 Participants | 16 Participants | 28 Participants |
| Caregiver Burden Inventory (CBI) | 57.00 units on a scale | 56.00 units on a scale | 57.00 units on a scale |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 30 Participants |
| Sex: Female, Male Male | 13 Participants | 12 Participants | 25 Participants |
| The Dementia Caring Knowledge Scale (DCKS) | 11.00 units on a scale | 12.00 units on a scale | 11.00 units on a scale |
| The Social Support Scale (SSRS) | 24.71 units on a scale STANDARD_DEVIATION 1.88 | 24.11 units on a scale STANDARD_DEVIATION 2.76 | 24.42 units on a scale STANDARD_DEVIATION 5.54 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 30 | 2 / 30 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: Baseline (pre-intervention)
Population: Withdrawal due to the death of the care recipient.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| an Offline Supportive Care Program | Caregiver Burden Inventory- Baseline (Month 0) | 56 score on a scale |
| mHealth Supportive Care Program | Caregiver Burden Inventory- Baseline (Month 0) | 57 score on a scale |
Primary
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.
Time frame: Post-intervention (Month 3)
Population: Withdrawal due to the death of the care recipient.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| an Offline Supportive Care Program | Caregiver Burden Inventory - Post-intervention (Month 3) | 52 score on a scale |
| mHealth Supportive Care Program | Caregiver Burden Inventory - Post-intervention (Month 3) | 48 score on a scale |
Secondary
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.
Time frame: Baseline (Pre-intervention)
Population: Withdrawal due to the death of the care recipient.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| an Offline Supportive Care Program | Dementia Caring Knowledge Scale-Baseline (Month 0) | 12.3 score on a scale | Standard Deviation 3.45 |
| mHealth Supportive Care Program | Dementia Caring Knowledge Scale-Baseline (Month 0) | 11.32 score on a scale | Standard Deviation 2.13 |
Secondary
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.
Time frame: Post-intervention (Month 3)
Population: Withdrawal due to the death of the care recipient.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| an Offline Supportive Care Program | Dementia Caring Knowledge Scale - Post-intervention (Month 3) | 16 score on a scale |
| mHealth Supportive Care Program | Dementia Caring Knowledge Scale - Post-intervention (Month 3) | 19 score on a scale |
Secondary
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.
Time frame: Baseline (Pre-intervention)
Population: Withdrawal due to the death of the care recipient.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| an Offline Supportive Care Program | Social Support Rating Scale - Baseline (Month 0) | 24.11 score on a scale | Standard Deviation 2.76 |
| mHealth Supportive Care Program | Social Support Rating Scale - Baseline (Month 0) | 24.71 score on a scale | Standard Deviation 1.88 |
Secondary
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.
Time frame: Post-intervention (Month 3)
Population: Withdrawal due to the death of the care recipient.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| an Offline Supportive Care Program | Social Support Rating Scale - Post-intervention (Month 3) | 31 score on a scale |
| mHealth Supportive Care Program | Social Support Rating Scale - Post-intervention (Month 3) | 32 score on a scale |