Status Approved
First Submitted Date
2021/02/09
Registered Date
2021/02/22
Last Updated Date
2021/02/17
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005922 |
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Unique Protocol ID | NECA-A-20-007 |
Public/Brief Title | medical cost estimation of frailty and cost-effectiveness of comprehensive integrated frailty management in primary care |
Scientific Title | medical cost estimation of frailty and cost-effectiveness of comprehensive integrated frailty management in primary care |
Acronym | ICOOP_Frail |
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 |
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Board Approval Number | NECAIRB20-021-1 |
Approval Date | 2020-07-14 |
Institutional Review Board Name | National Evidence-based Healthcare Collaborating Agency (Institutional Review Board) |
Institutional Review Board Address | 173, Toegye-ro, Jung-gu, Seoul, Republic of Korea |
Institutional Review Board Telephone | 02-2174-2851 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Changwon Won |
Title | professor |
Telephone | +82-2-958-8697 |
Affiliation | Kyung Hee University |
Address | 26, Kyungheedae-ro, Dongdaemun-gu, Seoul, Republic of Korea |
Contact Person for Public Queries | |
Name | Eunmi Ha |
Title | researcher |
Telephone | +82-2-958-2832 |
Affiliation | Kyung Hee University |
Address | 23, Kyungheedae-ro, Dongdaemun-gu, Seoul, Republic of Korea |
Contact Person for Updating Information | |
Name | Eunmi Ha |
Title | researcher |
Telephone | +82-2-958-2832 |
Affiliation | Kyung Hee University |
Address | 23, Kyungheedae-ro, Dongdaemun-gu, Seoul, Republic of Korea |
4. Status
Study Site | Multi-center Number of center : 6 | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2020-07-28 Actual | |
Target Number of Participant | 100 | |
Primary Completion Date | 2021-10-31 , Anticipated | |
Study Completion Date | 2021-12-31 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Dongdong Family Medicine Clinic | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2020-07-29 , | |
Recruitment Status by Participating Study Site 2 | ||
Name of Study | Dongbu-hanil Surgery Clinic | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2020-09-07 , | |
Recruitment Status by Participating Study Site 3 | ||
Name of Study | Mirae Family Medicine Clinic | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2020-07-28 , | |
Recruitment Status by Participating Study Site 4 | ||
Name of Study | ||
Recruitment Status | Recruiting | |
Date of First Enrollment | 2020-08-23 , | |
Recruitment Status by Participating Study Site 5 | ||
Name of Study | Haneul Family Medicine Clinic | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-02-15 , | |
Recruitment Status by Participating Study Site 6 | ||
Name of Study | Woori Family Medicine Clinic | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-02-15 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Ministry of Health & Welfare |
Organization Type | Government |
Project ID | NECA-A-20-007 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Kyung Hee University |
Organization Type | University |
7. Study Summary
Lay Summary | 1.Frailty, which is pre-stage of disorder, makes people impossible to earn their own living. Moreover, it is also the most important factor of the dementia and the stroke that cause people to enter long-term care facility. However, there is no efforts to figure out and develop management of frailty in primary care. Prevalence rate of frailty shows upward trends as age get increased. Elderly people who are in the stage of frailty has high probability of disorder, death, and hospitalization. Prevention of deterioration of elderly people’s function is necessary for healthy frailty. Efforts to synthetically manage and to evaluate the elderly’s function in primary care is also essential. Role of integrated care in primary care and community healthcare to diagnosis and prevent frailty was emphasized in Decade of Healthy Ageing(2020-2030) of WHO. KFACS revealed several risk factors of frailty and devised intervention methods by the factors through a study of frailty. An elderly person can have various risk factors, so integrative intervention method need to be provided. Thus, several types of comprehensive methods, which focus on providing the methods for elderly people who could have several risk factors are defined as integrated care program, and health condition of an elderly person who are experiencing frailty that received the care program is evaluated by frailty index. The importance of management of frailty would be figured out in this inquiry. Besides, the purpose of the inquiry is to analyze whether rate of hospitalization in acute period, IADL, state of frailty, health habits, activity for participating society and walking ability is improved through applying of integrated care program and pre-diagnosis in primary care. Lastly, it also has purpose to contribute to help to make healthy aging and to prevent disorder. 2.The inquiry was proceeded at 6 clinics: 5 clinics located at Seoul and 1 clinic located at Gyeongi-do. Frailty diagnosis was implemented to elderly people who visit primary care and their age over 70. 100 elderly people whose KFI_PC(Korean Frailty Index for Primary Care) of South Korea primary clinic is over 0.25 were randomly assigned into two different group: 50 of experimental group and 50 of control group. Doctors of experimental group provided treatment and consulted in terms of nutrition, exercise, sarcopenia, and rack of social activity, and decline in cognitive function based on educational materials and result of frailty index. The doctors, then, associated with health coaches. Health coaches keep maintaining to contact to the experimental group and associated with education and support for community. On the other hand, control group just received educational materials. And the table, that used for the employer in this research. The result was also figured out by the tablet. Moreover, education session was implemented in real time by utilizing educational materials suited for patients. Materials of candidates of the inquiry would be automatically associated with Health Coach. Re-evaluation would be conducted, 3 months and 6 months later, from the baseline evaluation. It is way to evaluate whether KFI_PC of the patients had been changed or not. 3.Primary result index includes patient’s frailty index records of hospitalization in recent 3 month, the number of usage of hospitalization, appetite, 5 times sit up from a chair, IADL, health habits, walking ability, and ability for participating. Expenses are evaluated by education time, consulting hours with health coach and expenses calculation. Cost effectiveness analysis is analyzed by comparing comparison of index between pre-program and post-program such as frailty index, hospitalization acute period hospital the number of employing hospitalization, daily living activity, participating for social activity, improvement of health habits, self-evaluation in terms of health, and satisfaction of doctors with the control group’s index. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Prevention |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Single |
Blinded Subject | Subject |
Allocation | RCT |
Intervention Type | Behavioral |
Intervention Description | 1.Intervention methods of integrated care program includes providing educational materials suitable for patients, regular evaluation of frailty risk factors, and association with support from community. 2.Nutrition education emphasizes importance and confirmation of balanced meal and taking protein. In case of exercise education, it implements complex exercises that includes resistance, endurance, balance, and flexibility. 3.Both groups received educational materials in terms of prevention of frailty at stage of participants’ confirmation. -The experimental group took clinical consultation from doctors and the health coach keep maintaining to contact and monitor them. Besides, the coach associated with community support. -The control group received educational materials only. |
Number of Arms | 2 |
Arm 1 |
Arm Label Experimental |
Target Number of Participant 50 |
|
Arm Type Experimental |
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Arm Description 1.Risk factors of patients such as nutrition, loss of muscle, lack of social activity, and declining in cognitive function are computed. Educational material that is suitable for patients in terms of factors is provided. 2.Program responsive to section that compute risk factors revealed through Korea primary care frailty index is applied to the experimental group. Details applied in to the program is followed: -Doctors of clinics conducted evaluation and medical consultation to the experimental group in their first visit based on frailty index and evaluated risk factors. -Health coach who was in charge of monitoring keep contacting to the patients and applied and associated with every program that is needed. |
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Arm 2 |
Arm Label No intervention |
Target Number of Participant 50 |
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Arm Type No intervention |
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Arm Description The control group received educational materials only(nutrition,exercise) |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (R00-R99)Symptoms, signs and abnormal clinical and laboratory findings, NEC (R54)Senility Frailty/A state of increased vulnerability to stressors, following declines in function and reserves across multiple physiologic systems, characterized by MUSCLE WEAKNESS; FATIGUE; slowed motor performance; low physical activity; and unintentional weight loss |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 70Year~No Limit |
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Description Standards to include participants: Select 100 participants who satisfied following requirements. 1. Over 70-years old elderly frailty patients 2. Person who is corresponding to over 3 of 5 sections in frailty survey 3. Person who is suspected by the doctor although he or she is corresponding to under 2 out of five in the survey 4. Among people who suspicious to frailty as result of the survey, person who got score over 0.25 in KFI_PC 5. Among the peole selected through upon procedures, person who provide written consent on inquiry participants agreement |
|
Exclusion Criteria |
Standards to exclude from the participants. Person who is not able to fulfil the requirements and any person who received doctors decisions that he or she is not suitable for the inquiry according to doctors and director of the inquiry’s notes. 1. Person who is unable to have a conversation and received diagnosis of dementia. 2. Person who is in the progress of treatment of cancer, stroke or got myocardial infarction within 6 month 3. Patient who have cold or acute period patients. |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | hospitalization in recent 3 month |
|
Timepoint | 0(baseline)/3month/6month |
|
Primary Outcome(s) 2 | ||
Outcome | IADL |
|
Timepoint | 0(baseline)/3month/6month |
|
Primary Outcome(s) 3 | ||
Outcome | states of frailty |
|
Timepoint | 0(baseline)/3month/6month |
|
Primary Outcome(s) 4 | ||
Outcome | health habits |
|
Timepoint | 0(baseline)/3month/6month |
|
Primary Outcome(s) 5 | ||
Outcome | activity for participating society |
|
Timepoint | 0(baseline)/3month/6month |
|
Primary Outcome(s) 6 | ||
Outcome | walking ability |
|
Timepoint | 0(baseline)/3month/6month |
|
Secondary Outcome(s) 1 | ||
Outcome | depression |
|
Timepoint | 0(baseline)/3month/6month |
|
Secondary Outcome(s) 2 | ||
Outcome | polypharmacy |
|
Timepoint | 0(baseline)/3month/6month |
|
Secondary Outcome(s) 3 | ||
Outcome | visual/auditory problem |
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Timepoint | 0(baseline)/3month/6month |
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Secondary Outcome(s) 4 | ||
Outcome | sleeping, napping problem |
|
Timepoint | 0(baseline)/3month/6month |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2021. 12 |
Way of Sharing | To be made available at a later date
(em0204@naver.com) |
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