- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01619592
Web-based Education for Diabetes Patients on Adaptable Insulin Schedules (Telediabetes)
The Belgian Quality of Life and Costs Study on Web-based Education for Diabetes Patients on Adaptable Insulin Schedules
Inclusion criteria: adult diabetes patients on multiple daily insulin injections or using an insulin pump; Internet users Exclusion criteria: having a severe mental illness Patients will be recruited during the conventional consult. If they want to participate, they will get detailed information regarding the study; after giving consent; they will sign the informed consent form and they will get a unique study number.
The patient will than complete a questionnaire on a secured website (https://) using the unique study number. After completing this questionnaire, the patient will be randomised either into a group 'standard care + direct start with web-based diabetes education' (intervention group) or they will enter into the other group (control) receiving standard care. Three months after the start of the study, all patients will be asked to complete the questionnaire again and the patients into the control group will also get access to 'standard care + web-based diabetes education'. The questionnaire will have to be completed on months 6, year 1 and year 2. At the time of completing the questionnaire, HbA1c will be determined. This is part of the routine examination in each participating hospital (UZGent and AZ Nikolaas). The determination of HbA1c is not study-specific but the value will be taken into the study.
The web-based questionnaire:
Patients will enter on a website including general study-information. They also have to explicitly click a button to proceed to the questionnaire. After clicking on 'I am prepared to participate in the study' they will see a second webpage retrieving some general information. After receiving this real basic information; they will be redirected to a secure website (https://) and will make use of a unique study number. Only the main researcher will have the possibility to link the general information to the unique study number.
The informed consent form:
The patient will be asked for added information. He/she will have to sign specific pages giving explicitly informed consent for information retrieved from the 'mutualiteit' (National Health Service - NHS).
On the NHS information will be asked regarding the health costs. These figures should make it possible to have a more objective figure of the costs associated to diabetes (care).
The patient can stop on every moment the study participation. Once decided he/she wants to stop, he/she will receive standard care.
Study hypotheses: the QoL will improve by the use of web-based diabetes education; there will be a reduction in costs using web-based diabetes education; there will be at least an equal-stay or improvement of the HbA1c while using web-based diabetes education.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Ghent, 벨기에, 9000
- Ghent University Hospital
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Sint-Niklaas, 벨기에, 9100
- AZ Nikolaas: Department of Endocrinology
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- adult diabetes patients on multiple daily insulin injections or using an insulin pump;
- Internet users
Exclusion Criteria:
- having a severe mental illness
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 |
---|---|
활성 비교기: Intervention group
webbased education (telemonitoring)
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Patients will be able to transmit their blood glucose values via the Internet to the diabetes professional and they will receive timely feedback.
"Timely" will be defined as 'as agreed between the patient and the diabetes professional', e.g.
every week on Friday afternoon.
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간섭 없음: control group
standard care
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Quality of Life (QoL)
기간: Baseline
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QoL will be measured via validated questionnaires: diabetes self-care questionnaire, Problem Areas in Diabetes, Diabetes Treatment and Satisfaction Questionnaire, Fear for Hypoglycaemia Questionnaire
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Baseline
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Quality of Life (QoL)
기간: month 3
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QoL will be measured via validated questionnaires: diabetes self-care questionnaire, Problem Areas in Diabetes, Diabetes Treatment and Satisfaction Questionnaire, Fear for Hypoglycaemia Questionnaire
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month 3
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Quality of Life (QoL)
기간: month 6
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QoL will be measured via validated questionnaires: diabetes self-care questionnaire, Problem Areas in Diabetes, Diabetes Treatment and Satisfaction Questionnaire, Fear for Hypoglycaemia Questionnaire
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month 6
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Quality of Life (QoL)
기간: year 1
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QoL will be measured via validated questionnaires: diabetes self-care questionnaire, Problem Areas in Diabetes, Diabetes Treatment and Satisfaction Questionnaire, Fear for Hypoglycaemia Questionnaire
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year 1
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Quality of Life (QoL)
기간: year 2
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QoL will be measured via validated questionnaires: diabetes self-care questionnaire, Problem Areas in Diabetes, Diabetes Treatment and Satisfaction Questionnaire, Fear for Hypoglycaemia Questionnaire
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year 2
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공동 작업자 및 조사자
협력자
수사관
- 연구 책임자: Johannes Ruige, MD, Phd, University Hospital, Ghent
- 수석 연구원: Heidi Buysse, Phd, University Hospital, Ghent
연구 기록 날짜
연구 주요 날짜
연구 시작
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 (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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