- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04249518
Video Extradition of Continuous Positive Airway Pressure - Influence on Compliance
연구 개요
상세 설명
Due to increasing age, BMI and increased focus on obstructive sleep apnea syndrome (OSAS) in the background population, an increasing number of obstructive sleep apnea (OSA) patients are expected to occur in the coming years. This is accompanied by a need for multiple deliveries of CPAP equipment, which is the recommended treatment. A large proportion of patients are young and healthy with their OSA. There is an increased focus on telemedicine and much of the control of patients has been transferred to ambuflex, where treatment effect or treatment problems can be more easily detected. Socioeconomically, the deliveries, together with the medical examination, are resource-intensive and they also take up a lot of the patient's time and often at distant times. The quality of disclosure and information varies greatly in both time and amount of information. The large amount of information can be difficult to remember for patients and relatives. Most investigations require more visits to the hospital and therefore potentially provide several days away from work.
A similar trial has never been made, but randomized studies have been made in the past where the delivery of CPAP or low compliance patients has been supported by a motivational video or teaching with good effect. Studies have also been conducted that have attempted to identify CPAP dropout and compliance based on gender, age, educational level and personality, with unemployment being the only contributing prognostic factor in the negative direction. It is well-studied that if patients suffer from insomnia, the onset of CPAP can be difficult and this patient group should be monitored more closely and possibly. have additional help for startup.
The video in this study provides a brief review of illness and treatment, instruction on assembling and adapting equipment, and answers to the most frequently asked questions. Both groups are given the same telephone numbers as usual, for questions and here it will be included in the study if there is a difference in the amount of contacts to the ambulatory. The video has been tested in the relevant setting before starting the project. M Gaglianos made in 1988 is a literature review showing that video teaching is good and more effective than traditional teaching methods, with effects on short-term but not long-term memory.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- candidate to CPAP
- over age of 18
Exclusion Criteria:
- Language issues
- sight or hearing handicap
- kognitive issues
- if drivers license is confiscated
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: nurse instruction of CPAP
Normal extradition.
45 minutes face to face with a nurse.
|
|
|
실험적: Video extradition
Access to 7 min video - explaining how to start CPAP and how to adjust the mask.
|
No drugs used.
The only difference in the to arms is the way the extradition is.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
compliance in percentage
기간: one month.
|
Compliance at one month follow up.
Minimum 0 % maximum 100 % compliance.
|
one month.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Depression
기간: one month.
|
Depression measured by major depression index (MDI) questionnaire.MDI total score < 20 being normal and not depressed.
MDI total score > 29 indicating severe depression.
|
one month.
|
|
Influencer
기간: one month.
|
Education level registered by ISCED 2011 levels of education.
Level 0-8.
8 being doctoral or equivalent.
0 being Early childhood Education (01 Early childhood educational development)
|
one month.
|
|
Insomnia
기간: One month .
|
Insomnia measured by insomnia severity index (questionnaire).
0-12 points.
0 being no problems facing a sleep.
12 having lots og trouble falling a sleep.
|
One month .
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jesper Bille, MD, University Aarhus
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 15022020
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .