- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02638246
Incentives for Internet-based Adherence to SMBG for Teens With T1D
Incentives for Internet-based Glucose Testing in Adolescent Type 1 Diabetes
연구 개요
상태
상세 설명
Intensive glycemic control among diabetics decreases the risk of both the development and progression of a number of medical complications associated with diabetes. Self-monitoring blood glucose is a critical component of diabetes self-management and is correlated with improvements in glycemic control. Nevertheless, adherence to blood glucose monitoring is generally poor, particularly among youth, with one study reporting that only ~ 25% of adolescents adhered to the recommended frequency of blood glucose testing.
The current study will use a powerful, scientifically-based behavioral intervention - contingency management (CM) to increase self-monitoring of blood glucose and improve glycemic control among adolescents with Type 1 diabetes. CM involves giving incentives for objective evidence of a target behavior and has been shown to have a robust and reliable impact in promoting behavior change. Our previous research used the Internet to objectively monitor smoking and reinforce smoking cessation (via video recorded carbon monoxide submissions), which resulted in robust increases in smoking abstinence. The current proposal extends this effective Internet-based CM intervention to address the significant health issue of non-adherence to blood glucose testing and glycemic control among youth. Two groups of non-adherent adolescents will be recruited. One group will earn incentives over the Internet for submitting webcam recorded videos that show them testing their blood glucose. A different group will be given standard care recommendations for blood glucose testing and management and will be encouraged to submit glucose monitoring videos, but incentives will not be delivered contingent on submissions (instead, they will earn monetary incentives independent of video submissions, but in an overall amount that matches the earnings of a participant in the other group). The purpose of the study is to evaluate the feasibility, convenience, and efficacy of using Internet-based CM to increase blood glucose monitoring in adolescent Type 1 diabetics.
Combining the accessibility of the Internet with a powerful, evidence-based behavioral intervention can have profound effects on adherence to diabetes self-management in this important population. Improving adherence to diabetes management in adolescents is a significant public health issue - serious medical complications, such as heart disease and nerve damage, that would develop with poor glycemic control can be avoided. Importantly, the current study offers a scientifically-based behavioral intervention that could be applied to a range of populations and behavior relevant to adherence with diabetes regimens (e.g., adults, medication adherence, carbohydrate counting, insulin dose adjustment, etc.).
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diagnosed with Type 1 diabetes for at least one year
- Self-reported self-monitoring blood glucose less than four times per day
- Lived in a home with Internet access
- No travel plans within 2 months of enrolling in the study
- Read and spoke English
Exclusion Criteria:
- Diagnosis other Type 1 diabetes within one year of screening
- Not attending regular clinic appointment within 3 months of screening
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Contingent
Participants in this group received incentives contingent on meeting pre-specified daily blood-glucose testing adherence goals.
|
Blood glucose monitoring was verified by videos uploaded to a secure server.
Participants in the experimental group received incentives for adherence whereas participants in the control group received adherence independent of adherence.
|
|
활성 비교기: Noncontingent
Participants in this group received incentives independent of meeting pre-specified daily blood glucose testing adherence goals.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Daily frequency of self-monitoring blood glucose
기간: 45 days
|
45 days
|
|
Percentage of days conducted at least 4 tests per day.
기간: 45 days
|
45 days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Acceptability of the intervention
기간: 45 days
|
This was measured using a Treatment Acceptability Questionnaire
|
45 days
|
|
Feasibility
기간: 45 days
|
Feasibility was based on willingness to participate (recruitment), adherence with the video submission protocol, and attrition
|
45 days
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Bethany Raiff, PhD, Rowan University
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 연구와 관련된 용어
기타 연구 ID 번호
- R21HD061683-02 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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. .