Evaluation of a Diabetes Treatment and Education Program for Insulin Pump Therapy (INPUT) (INPUT)
Evaluation of a Newly Developed Treatment and Education Program (INPUT) for Diabetic Patients Performing an Insulin Pump Therapy
연구 개요
상세 설명
INPUT is a self-management-based treatment and education program for diabetic patients with an insulin pump (CSII). It is designed to empower patients to adequately perform their therapy in daily life and to integrate their diabetes and their insulin pump into their lifes in order to enhance quality of life.
INPUT ist tested in an randomized controlled trial (RCT) with a waiting-list control group since no certified and effective treatment and education program for CSII exists.
This study is a multi-center study. Study centers are specialized diabetes practices throughout Germany. Patients will be approached by their respective practice and informed about the study. Study measurements as well as the conduct of INPUT will take place at the respective practice.
Baseline measurement will take place 2 weeks prior to the beginning of INPUT. After completion of baseline measurement, all patients from one study center will be randomized centrally by the Research Institute of the Diabetes Academy Mergentheim (FIDAM). 2 weeks and 6 months after the completion of INPUT, follow-up measurements will be conducted at the respective study center.
HbA1c as a marker of glycemic control will be analyzed in a central laboratory. Secondary outcome measures will be assessed via psychometrically tested questionnaires, Case Reports Forms, or patient files.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Neuss, 독일, 41462
- Diabetologische Schwerpunktpraxis Neuss
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Existing insulin pump therapy
- Prior participation in a structured diabetes education program
- HbA1c ≥ 7,5% but ≤ 13%
- Ability to understand, speak and write German language
- informed consent (if necessary, informed consent of the parents)
Exclusion Criteria:
- Diabetes duration < 1 year
- severe organic disease preventing a regular participation in the training course
- pregnancy
- severe cognitive impairment
- current treatment of psychiatric disorder
- renal disease requiring dialysis
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 |
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실험적: INPUT
INPUT consists of 12 lessons comprising all relevant information in order to treat diabetes with an insulin pump.
Patients learn to effectively use the different features of their pump in order to improve not only glycemic control but also to improve the implementation of pump therapy in daily life.
Psychological and motivational aspects of living with diabetes and living with an insulin pump are addressed as well.
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Treatment and education program based on the self-management theory of behavioral medicine. The program is delivered by certified and specially trained diabetes educators.
다른 이름들:
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간섭 없음: Waiting list
Patients are randomly assigned to the waiting list.
After completion of the 6-month follow-up, these patients will also receive training with INPUT.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Changes in Glycemic Control Measured by A1c
기간: 6 months
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Difference between baseline A1c and A1c at the 6-month follow-up
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Hypoglycaemia Awareness
기간: 6 months
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The hypoglycemia awareness questionnaire provides a score indicating the severity of hypoglycaemia unawareness.
This scale ranges from 0 (maximum hypoglycaemia awareness) to 7 (minimum hypoglycaemia awareness), where a score of 4 suggests reduced hypoglycaemia awareness.
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6 months
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Diabetes Empowerment
기간: 6 months
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Empowerment is measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.
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6 months
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Problem Areas in Diabetes
기간: 6 months
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The Problem Areas in Diabetes Scale (PAID) assesses the psychosocial adaptation to the burden of living with and treating diabetes.
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6 months
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Satisfaction with current treatment
기간: 6 months
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Satisfaction with current treatment is assessed via a 10-item scale.
The total score ranges from 10 to 60 with lower scores indicating higher satisfaction.
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6 months
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Diabetes Self-Management
기간: 6 months
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The Diabetes Self-Management Questionnaire is a self-report measure of patients' self-care.
The level of self-care is assessed via Likert scales.
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6 months
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Diabetes Distress
기간: 6 months
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The Diabetes Distress Scale (DDS) assesses diabetes-related stressors due to living and treating diabetes.
Different aspects of distress are covered: emotional burden, physician-related, regimen-related, diabetes-related interpersonal
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6 months
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Health-related Quality of Life
기간: 6 months
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Health-related quality of life focuses on the health-specific aspects of quality of life and dealing with a chronic condition such as diabetes
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6 months
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Depressive symptoms
기간: 6 months
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The presence and extent of typical depressive symptoms are assessed via self-report
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6 months
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Attitudes towards insulin pump therapy
기간: 6 months
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Specific attitudes towards different aspects of insulin pump therapy are assessed via Likert scales.
The questionnaire consists of 6 subscales that can be placed within 4 dimensions: (I) Expectations on insulin pump therapy (subscale: achieving better glycaemic control) (II) Perceived advantages of an insulin pump (subscale: gaining more flexibility) (III) Ease of use (subscales: design + functionality) (IV) Psychosocial effects and barriers (subscales: technological dependence + impaired body image)
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6 months
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Severe hypoglycaemia
기간: 6 months
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The incidence of severe hypoglycaemia in the past six months is assessed via Case Report Forms.
Severe hypoglycaemia is defined as requiring third party assistance or medical intervention for treating hypoglycaemia.
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6 months
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공동 작업자 및 조사자
스폰서
협력자
수사관
- 수석 연구원: Norbert Hermanns, PhD, Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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