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임상시험 NCT03576430 (SongDance)은(는) Diabetes Mellitus, Type 2, Stress에 대해 미상 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
The SongDance Study: Stress, Ongoing Self- Monitoring and Diabetes, Nerve Stimulation and Cognitive Empowerment 160 자택
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT03576430 (SongDance)은(는) Diabetes Mellitus, Type 2, Stress에 대해 알아보는 중재연구입니다. 현재 상태는 미상이며, 연구는 2018년 5월 31일에 시작되어 160명의 참여자를 모집하고 있습니다. Herlev Hospital이(가) 진행하며, 2020년 2월 28일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2019년 7월 15일에 갱신되었습니다.
간단한 개요
Type 2 diabetes (DM2) I may be associated with low level of Quality of Life (QOL), depression, persistent stress and autonomic nervous system dysfunction (ANSD). A new biological measure measuring the Pressure Pain Sensitivity (PPS) of the chest bone has been found to be a marker for persistent stress and ANS function, and linked to depression, QOL, chronic inflammation and HbA1c. An intervention which uses the PPS m...더 보기
상세한 설명
Introduction About 350 million people worldwide have type 2 diabetes (DM2). Approximately 85% of these patients are controlled in the primary health care.
A high level of personal care, i.e. high empowerment, is a pre-requisite for successful outcome of their diabetes disease. Therefore, all patients are encouraged to measure their blood glucose levels several times a week or daily, depending on the type of treatmen...
더 보기공식 제목
The SongDance Study: Stress, Ongoing Self- Monitoring and Diabetes, Nerve Stimulation and Cognitive Empowerment
질환명
Diabetes Mellitus, Type 2, Stress출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- SongDance
- H-17034836
NCT 번호
실제 연구 시작일
2018-05-31
최신 업데이트 게시
2019-07-15
예상 연구 완료일
2020-02-28
계획된 등록 인원
160
연구종류
중재연구
단계/상
해당 없음
상태
미상
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
삼중맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
활성 대조군active active stress handling | active stress handling biofeed back stress handling |
비개입control no stress handling | 해당 없음 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Change in Hemoglobin A1C | numeric scale 30-150 mmol/mol; higher value indicates worsening of diabetes control | 0, 3 and 6 months |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
pressure pain sensitivity | numeric scale, range 30-100; higer values indicate more stressed person | 0, and 6 months |
Correlation between changes in pressure pain sensitivity and Hemoglobin A1C | see above, numeric scale; range 0-1, higher correlation indicates higher association between mean bood glucose and stress | 0, and 6 months |
Personal diabetes empowerment scale (DES-ST) | 4 questions, range 1-5, sum score, numeric scale range 4-20; higher values indicate higher empowerment | 0, and 6 months |
quality of life index (WHO-5) | 5 questions, sum score, numeric scale, range 0-25, higher values indicate better quality of life | 0, and 6 months |
Physical and mental health (SF 36) | quality of life, 11 questions, sum score, numeric scale, range 0 - 100; higher values indicate better Physical and mental health | 0, and 6 moths |
Depression (MDI questionnaire) | depression symptoms, 10 questions, range 0-6, sum score, numeric scale, range 0-60; higher values indivate more depressed person | 0, and 6 moths |
Number of clinical stress symptoms measured by a specially designed questionnaire | Number of stress symptoms, sum of 56 questions, numeric scale; range 0-56, higher values indicate more stressed person | 0, and 6 moths |
Sleepiness score (Epworth) | 8 questions, range 0-3, sum score, numeric scale; range 24; higher values indicate increased tiredness | 0, and 6 months |
Diabetes treatment satisfaction questionnaire (DTSQ) | treatment satisfaction: 8 questions, range 0-6, sum score; range 0-48, the higher the more satisfied | 0, and 6 months |
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
Inclusion criteria
- Diagnosed DM2,
- HbA1c: ≤ 9 % (75 mmol/mol)
- BMI < 40.
- PPS ≥ 60 units;
- Age < 75 years;
- Manage the Danish language for proper use of instructions,
- Actively express to accept to conduct minimum 20 minutes of self-care daily.
- Use of insulin as basal-bolus regime (i,.e. the combination of long-term acting insulin as basal insulin and short-term lasting insulin as bolus injections before meals)
- Use of Beta blockade medication
- HbA1c > 9 % (75 mmol/mol)
- Previously diagnosed and treated for a psychiatric disorder, except for depression.
- A chronic competing disorder that statistically is life-shortening (such as advanced cancer with metastases).
- A chronic competing disorder that is not heart disease and which clearly impairs the patient's quality of life /e.g. COPD, cancer, chronic pain syndrome).
- Patients who cannot fend for themselves.
- One or more of the following complications: diabetic retinopathy that needs specific treatment, or nephropathy (i.e. plasma creatinine ≥ 200 umol/L))
Herlev Hospital연구 책임자
Jens Faber, 책임연구자, professor, Herlev Hospital
연락처 정보가 없습니다.
1 1개국에 임상시험 장소
Department of Medicine, Herlev Hospital, Herlev, 2730, Denmark