Status Approved
First Submitted Date
2021/03/29
Registered Date
2021/03/31
Last Updated Date
2021/03/08
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
| CRIS Registration Number |
KCT0006045 |
|---|---|
| Unique Protocol ID | MDCR-20-013-L |
| Public/Brief Title | A study of the effects of physical fatigue and pain management in caregivers using mobile apps |
| Scientific Title | Effect of novel mobile app on physical fatigue and pain management of caregivers |
| Acronym | MAPPC |
| MFDS Regulated Study | No |
| IND/IDE Protocol | No |
| Registered at Other Registry | No |
| Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
| Board Approval Status | Submitted approval |
|---|---|
| Board Approval Number | MDCR-20-013-L |
| Approval Date | 2020-11-25 |
| Institutional Review Board Name | Institutional review board Daegu Catholic university Medical Center |
| Institutional Review Board Address | 33, Duryugongwon-ro 17-gil, Nam-gu, Daegu |
| Institutional Review Board Telephone | 053-650-4423 |
| Data Monitoring Committee |
3. Contact Details
| Contact Person for Principal Investigator / Scientific Queries | |
|---|---|
| Name | dong rak kwon |
| Title | professor |
| Telephone | +82-53-650-3062 |
| Affiliation | Daegu Catholic University Medical Center |
| Address | 33 Duryugongwon-ro 17-gil, Nam-gu, Daegu, Republic of Korea |
| Contact Person for Public Queries | |
| Name | dong rak kwon |
| Title | professor |
| Telephone | +82-53-650-3062 |
| Affiliation | Daegu Catholic University Medical Center |
| Address | 33 Duryugongwon-ro 17-gil, Nam-gu, Daegu, Republic of Korea |
| Contact Person for Updating Information | |
| Name | dong rak kwon |
| Title | professor |
| Telephone | +82-53-650-3062 |
| Affiliation | Daegu Catholic University Medical Center |
| Address | 33 Duryugongwon-ro 17-gil, Nam-gu, Daegu, Republic of Korea |
4. Status
| Study Site | Single | |
|---|---|---|
| Overall Recruitment Status | Not yet recruiting | |
| Date of First Enrollment | 2021-04-05 Anticipated | |
| Target Number of Participant | 23 | |
| Primary Completion Date | 2021-09-30 , Anticipated | |
| Study Completion Date | 2021-11-30 , Anticipated | |
| Recruitment Status by Participating Study Site 1 | ||
| Name of Study | Daegu Catholic University Medical Center | |
| Recruitment Status | Not yet recruiting | |
| Date of First Enrollment | 2021-04-05 , | |
5. Source of Monetary / Material Support
| 1. Source of Monetary/Material Support | |
|---|---|
| Organization Name | Daegutechnopark |
| Organization Type | Others |
| Project ID | |
6. Sponsor Organization
| 1. Sponsor Organization | |
|---|---|
| Organization Name | Daegutechnopark |
| Organization Type | Others |
7. Study Summary
| Lay Summary | The purpose of this study is to study the application value of a mobile app that provides correct exercise education and physical activity management of caregivers who provide care to the elderly and the disabled. |
|---|
8. Study Design
| Study Type | Interventional Study |
|---|---|
| Study Purpose | Basic Science |
| Phase | Not applicable |
| Intervention Model | Single Group |
| Blinding/Masking | Open |
| Allocation | Not Applicable |
| Intervention Type | Others (mobile app and smart device) |
| Intervention Description | A mobile application that collects self-recording information on caring activity history and physical burden and physical activity information through a smart device is provided on a tablet PC. |
| Number of Arms | 1 |
| Arm 1 |
Arm Label group using mobile app |
|
Target Number of Participant 23 |
|
|
Arm Type Others |
|
|
Arm Description A mobile application that collects self-recording information on caring activity history and physical burden and physical activity information through a smart device is provided on a tablet PC. |
9. Subject Eligibility
| Condition(s)/Problem(s) |
Not Applicable-Etc
Adults engaged in work providing care services |
|---|---|
| Rare Disease | No |
| Inclusion Criteria |
Gender Both |
|
Age 19Year~80Year |
|
|
Description -A care provider who performs care work more than 4 days a week -Those who can communicate -Those who can understand the content of the question -Those who did not have musculoskeletal disorders prior to caring activities -Those who understand the purpose of the study and voluntarily participate |
|
| Exclusion Criteria |
-Those with central nervous system disorders -Those with peripheral neuropathy -Those with neuromuscular junction disorder -Those suffering from muscle disease -Those with a history of surgery for brain, spine, or peripheral neuropathy -Bone deformation or joint contraction -Hypersensitivity reaction to surface electrode -Senile dementia, cognitive dysfunction and serious mental illness -Alcohol or drug addiction -In case of refusal to participate or unable to communicate in Korean -Other patients judged to be inappropriate |
| Healthy Volunteers | Yes |
10. Outcome Measure(s)
| Type of Primary Outcome | Not applicable | |
|---|---|---|
| Primary Outcome(s) 1 | ||
| Outcome | Do not record caring activity history on the mobile app |
|
| Timepoint | 5day |
|
| Secondary Outcome(s) 1 | ||
| Outcome | pain index |
|
| Timepoint | everyday |
|
| Secondary Outcome(s) 2 | ||
| Outcome | EMG measurements |
|
| Timepoint | caring activity 1day, 21days, 42days |
|
| Secondary Outcome(s) 3 | ||
| Outcome | activity(Number of steps, walking distance,Calories burned) |
|
| Timepoint | everyday |
|
| Secondary Outcome(s) 4 | ||
| Outcome | caring activity history |
|
| Timepoint | everyday |
|
| Secondary Outcome(s) 5 | ||
| Outcome | Maximum Voluntary Isomeric Contraction |
|
| Timepoint | initiate, end |
|
11. Study Results and Publication
| Result Registered | No |
|---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
| Sharing Statement | No |
|---|
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