- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01317459
Guided Self-determination - Promoting Self-management in Type 1 Diabetes (GSD)
Using Guided Self-determination (GSD) to Promote Improved Self-management in Adults With Type 1 Diabetes - an Intervention Study.
Background: 50% of people with diabetes are living with too high blood sugars and increased risk of diabetes related complications together with poor quality of life. The need to improve diabetes care by better enabling patients to utilise their individual and local resources to self-manage the condition is widely recognized, yet there is a lack of access to evidence-based patient-centred healthcare interventions. At present the individual patient's judgement of own concrete situation mostly remains unexplored and insufficiently used in decision-making causing that problems perceived by the patient in living with the illness remain unrecognised and insufficiently resolved.
Aim and Methods: Guided self-determination (GSD) is an educational method developed to promote patient autonomy, participation, skills building and intrinsic motivation. In this evidence-based group-intervention the main objective is to implement and evaluate GSD through a randomised controlled trial. GSD methods will be performed seven times for the intervention group. The control group will receive traditional out-patient consultations - 'care as usual' Outcome measures will be performed at baseline, after 9 and 18 months. The project will focus on adults with type 1 diabetes (18-55 yrs) where an improvement will be highly cost-effective in preventing late complications and enhanced psychosocial health. GSD is presumably an intervention providing psychosocial support applicable in busy clinical practice.
An alliance is established between Haukeland University Hospital, Norway and Steno Diabetes centre, Copenhagen, Denmark, Centre of Evidence-Based Practice, Bergen University College, and Bergen University to conduct this intervention and thus make the best possible use of interrelated knowledge within the issue.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Bergen, 노르웨이, 5021
- Helse Vest HF, Haukeland University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Diabetes type one, HbA1c >= 8%
Exclusion Criteria:
Pregnancy, decreased cognitive function and/or serious mental health disturbances, language barriers to the Norwegian language
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 생활 상담
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Group counselling
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실험적: No intervention
Care as usual
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Group counselling
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Change in HbA1c
기간: 0, 9 and 18 months
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0, 9 and 18 months
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Who 5
기간: 0, 9 and 18 months
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0, 9 and 18 months
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TSRQ scales
기간: 0, 9 and 18 months
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0, 9 and 18 months
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PAID scales
기간: 0, 9 and 18 months
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0, 9 and 18 months
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Rosenberg's self-esteem scale
기간: 0, 9 and 18 months
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0, 9 and 18 months
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PCD scales
기간: 0, 9 and 18 months
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0, 9 and 18 months
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HCCQ scales
기간: 0, 9 and 18 months
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0, 9 and 18 months
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DDS scales
기간: 0, 9 and 18 months
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0, 9 and 18 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Marit Graue, RN, PhD, Bergen University College
간행물 및 유용한 링크
일반 간행물
- Mohn J, Igland J, Zoffmann V, Peyrot M, Graue M. Factors explaining variation in self-esteem among persons with type 1 diabetes and elevated HbA1c. PLoS One. 2018 Aug 10;13(8):e0201006. doi: 10.1371/journal.pone.0201006. eCollection 2018.
- Mohn J, Graue M, Assmus J, Zoffmann V, Thordarson H, Peyrot M, Rokne B. The effect of guided self-determination on self-management in persons with type 1 diabetes mellitus and HbA1c >/=64 mmol/mol: a group-based randomised controlled trial. BMJ Open. 2017 Jul 3;7(6):e013295. doi: 10.1136/bmjopen-2016-013295.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
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