- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01460095
Improving Access to HbA1c in Sub Saharan Africa (IA3)
Improving Access to HbA1c Measurement in Sub-Saharan Africa
연구 개요
상세 설명
The objective is to determine whether the introduction of routine affordable HbA1c determination with immediate feedback to patients and relevant education in an underserved population without any further intervention on drug supply would significantly improve diabetes control. As this will be an after-versus-before type study, each patient will be his own control.
Study setting The study will be undertaken in 10 existing diabetes care centre in two countries, including 4 regional centers in Guinea, a West African country of 10 millions inhabitants, and 6 regional centers in Cameroon, a Central African country of 18 million inhabitants.
The health districts covered in Guinea are Conakry, Labe, Kankan and Boke each being situated in a different ecological and cultural areas. In Cameroon, the health districts covered are Biyem Assi in Yaoundé, Garoua, Limbe, Ebolowa, Bamenda, Bafoussam also covering the 4 ecological zone of Cameroon.
All these health districts have existing diabetes care centre with trained personnel run in public hospital with prices and medicine affordable to most of the population covered. However, none of these centers have an HbA1c machine, and diabetes control is mainly evaluated using blood glucose, most often fasting.
Target population The aim is to provide the service to all patients followed in the selected centers at low cost however the first eligible 1000 patients will be included in the formal intervention free of charge.
Eligibility All patients with a physician-confirmed diagnosis of diabetes and who have been followed in the diabetes centre for at least one year are eligible Sample size In order to detect a difference of 1 unit (1% glycated haemoglobin) between to samples with a standard deviation of 1.2%, alpha coefficient of 0.001 and 0.8 power using a two-sided test, a minimum population of 80 subjects is required. The minimum sample size if alpha is 0.01 is 55 subjects. We therefore decided a sample size of 100 patients per centre in order to be able to analyze data taking into account center or physician effect. It thus give an overall sample size of 1000 subjects.
Sampling method We will use a systematic sampling, enrolling consecutive eligible patients volunteering to participate until completion of the sample size in each individual centre.
Inclusion All eligible patients, not intending to migrate from the study site within 1 year, and volunteering to participate will be enrolled. At inclusion the following will record of demographic characteristics, past medical history, characteristics of diabetes, evaluation of patient knowledge, and measurement of anthropometric characteristics, blood pressure, haematocrit, HbA1c, and urinary albumin excretion at baseline.
Intervention and follow up:
Data will be collected using a clinical record form designated to this effect. The intervention will consist of the measurement of HbA1c at baseline, 3, and 6 months with immediate feedback to patients and provision of targeted education after each determination, on level, significance, and targets.
Treatment will follow usual guidelines with no additional intervention. Adjustment of treatment will be done by the health care personnel in a treat-to-target fashion. No change in drug supply will be introduced. No specific recommendation will be given concerning the frequency of hospital visit between the study visits at baseline, month 3, 6, and 12. Each centre will continue with usual follow up frequency.
At month 12, we will repeat the evaluation of patient knowledge, and the measurement of anthropometric characteristics, blood pressure, haematocrit, HbA1c, and urinary albumin excretion for comparison to baseline.
Timeframe
- Start date: Month 7
- End of enrollment: Month 12
- End of follow-up of last patient enrolled: Month 24
Outcome measures
Primary outcome: Change in HbA1c from baseline to 12 months
Secondary outcomes:
- Change in percentage of patients at HbA1c target from baseline to 12 months
- Change in urinary albumin excretion from baseline to 12 months The other measures will serve for the interpretation of data Deliverables
- Dataset for each centre between Month 24 and Month 26
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Boke, 기니
- Boke Regional Hospital
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Conakry, 기니
- CHU Donka
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Kankan, 기니
- Kankan Regional Hospital
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Labe, 기니
- Labe regional Hospital
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Bafoussam, 카메룬
- Bafoussam District Hospital
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Centre
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Yaounde, Centre, 카메룬
- Yaoundé Central Hospital
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North
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Garoua, North, 카메룬
- Garoua Regional Hospital
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North West
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Bamenda, North West, 카메룬
- Bamenda Regional Hospital
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South West
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Buea, South West, 카메룬
- Buea Regional Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Confirmed diabetes mellitus irrespective of type
- Patients who have been followed regularly for at least one year prior to inclusion in the target health facilities
- Adult age (18 years and over)
Exclusion Criteria:
- Individuals planning to migrate from study sites within one year
- Any intercurrent acute illness
- Enrollment in any other concomitant intervention study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: HbA1c measurement and education
3-monthly Hba1c determination with immediate feedback and targeted education delivered to all participants
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three-monthly point of care measurement of HbA1c with immediate feedback to patients and provision of interpretation and targeted one-to-one education
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
one year change in glycated haemoglobin (HbA1c)
기간: Baseline and 12 months
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Baseline to 12 months individual change in HbA1c level
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Baseline and 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
One-year change in proportion of patients reaching HbA1c targets
기간: Baseline and 12 months
|
Baseline to 12 months change in proportion of patients reaching HbA1c targets in each participating centre and in the overall population
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Baseline and 12 months
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One-year change in urinary albumin excretion
기간: Baseline and 12 months
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Baseline to 12 months individual change in early morning sample urinary albumin excretion
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Baseline and 12 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Eugene Sobngwi, MD, PhD, Newcastle University, UK and Yaounde Central Hospital, Cameroon
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. .
HbA1c measurement and education에 대한 임상 시험
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University of OxfordBeijing Normal University; Beijing Stars and Rain Education Institute for Autism완전한아동 학대 | 부모-자녀 관계 | 자폐 스펙트럼 장애 | 육아 | 아동 행동 문제 | 가족 관계 | 정신 건강 문제중국