Optimizing Self-Management Adherence and Glycemic Control in Older Teens With Type 1 Diabetes: The Teenwork Study
연구 개요
상세 설명
Glycemic control deteriorates during adolescence as parents become less involved in teens' diabetes management and adherence declines. Thus, there is a need to improve adherence and glycemic control in mid to older teens with type 1 diabetes by strengthening the teens' self-efficacy for daily diabetes self-management to help prepare them for the transition between pediatric and adult care. This 18-month, multi-center RCT is designed to increase frequency of blood glucose monitoring and improve glycemic control in teens with type 1 diabetes through a behavioral intervention called Teenwork with or without text message reminders to check blood glucose levels.
We will implement and evaluate the Teenwork intervention and text message reminders to check blood glucose levels in a 2x2 factorial design in which 300 participants, across two sites, will be randomized to 1 of 4 groups: Teenwork, Text Message, Teenwork/Text Message, or Usual Care.
Participants in the Teenwork Group will meet with a research assistant during each study visit to review strategies for improving self-care, including self-management and self-advocacy, focusing on two areas: blood glucose monitoring and insulin administration. Participants in the Text Message Group will be instructed in the use of the text messaging system. They will receive 2-way text message reminders to check blood glucose levels at self-selected times and to reply by text message with blood glucose results. Participants in the Teenwork/Text Message Group will receive both the Teenwork intervention and the text message reminders (as described above). Participants in the Usual Care Group will receive the same intervention as the Teenwork/Text Message Group, but not until after 1 year.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02215
- Joslin Diabetes Center
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Texas
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Houston, Texas, 미국, 77030
- Texas Children's Hospital/Baylor College of Medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Youth age 13-17 years
- Diagnosis of type 1 diabetes according to American Diabetes Association criteria
- Diabetes duration ≥6 months
- Daily insulin dose ≥0.5 units/kg
- A1c ≥6.5%and ≤11%
- Willingness to check blood glucose levels
- Cell phone with text messaging ability
Clinic attendance
- At least one clinic visit at the clinical site in the previous 12 months
- Anticipated care at the clinical site for the duration of the study
- Fluency in English (reading, writing, and speaking) for child and parent/guardian
- Enrollment no later than December of the teen's senior year of high school
Exclusion Criteria:
- Pregnancy in the youth participant
- Significant developmental or cognitive disorder that would prevent full study participation
- Significant mental illness, defined by either major psychiatric disorder (e.g., diagnosed eating disorder, major psychoses) or inpatient psychiatric admission within the previous 6 months
- Failure to understand that the 2-way text messaging does NOT result in immediate response from a health care professional; this will be assessed at the time of informed consent/assent
- Participation in another intervention study within the 3 months prior to enrollment
- Other psychosocial, medical, or family issues, as assessed by the teen's pediatric team, that would prevent full study participation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Teenwork Group
Teen/family will receive the Teenwork intervention at each quarterly study visit.
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Set of psychoeducational modules focused on optimizing diabetes self-care through blood glucose monitoring and insulin administration
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실험적: Teenwork/Text Message Group
Teen/family will receive the Teenwork intervention at each quarterly study visit.
Teen will receive text message reminders to check blood glucose levels at self-selected times.
|
Set of psychoeducational modules focused on optimizing diabetes self-care through blood glucose monitoring and insulin administration
Text message reminders to check blood glucose levels at self-selected times
|
|
실험적: Text Message Group
Teen will receive text message reminders to check blood glucose levels at self-selected times.
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Text message reminders to check blood glucose levels at self-selected times
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간섭 없음: Usual Care Group
Teen/family will receive routine clinical care for the first year of the study (the time period for assessment of primary outcomes).
After year 1, teen/family will receive the Teenwork intervention at each remaining study visit and teen will receive text message reminders to check blood glucose levels at self-selected times.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in glycemic control from baseline to 1 year
기간: Baseline and 1 year
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Glycemic control will be assessed as A1c (DCCT-standardized assay, ref range 4.0-6.0%)
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Baseline and 1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in glycemic control from 1 year to 18 months
기간: 1 year and 18 months
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Glycemic control will be assessed as A1c (DCCT-standardized assay, ref range 4.0-6.0%)
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1 year and 18 months
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Psychosocial factors (self-report surveys)
기간: Baseline, 6 months, 1 year, 18 months
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We will assess psychosocial factors (e.g., diabetes-specific family conflict, diabetes burden, negative affect around blood glucose monitoring, quality of life, depressive symptoms, self-efficacy, disordered eating behaviors) every 6 months
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Baseline, 6 months, 1 year, 18 months
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Barbara J. Anderson, PhD, Texas Children's Hospital/Baylor College of Medicine
간행물 및 유용한 링크
일반 간행물
- Commissariat PV, Volkening LK, Guo Z, ElBach JL, Butler DA, Laffel LM. Associations between major life events and adherence, glycemic control, and psychosocial characteristics in teens with type 1 diabetes. Pediatr Diabetes. 2018 Feb;19(1):85-91. doi: 10.1111/pedi.12523. Epub 2017 Apr 19.
- McGill DE, Volkening LK, Butler DA, Wasserman RM, Anderson BJ, Laffel LM. Text-message responsiveness to blood glucose monitoring reminders is associated with HbA1c benefit in teenagers with Type 1 diabetes. Diabet Med. 2019 May;36(5):600-605. doi: 10.1111/dme.13929. Epub 2019 Feb 25.
- Cecilia-Costa R, Volkening LK, Laffel LM. Factors associated with disordered eating behaviours in adolescents with Type 1 diabetes. Diabet Med. 2019 Aug;36(8):1020-1027. doi: 10.1111/dme.13890. Epub 2019 Mar 4.
- McGill DE, Laffel LM, Volkening LK, Butler DA, Levy WL, Wasserman RM, Anderson BJ. Text Message Intervention for Teens with Type 1 Diabetes Preserves HbA1c: Results of a Randomized Controlled Trial. Diabetes Technol Ther. 2020 May;22(5):374-382. doi: 10.1089/dia.2019.0350.
- Harrington KR, Shapira A, Volkening LK, Butler DA, Anderson BJ, Wasserman RM, Laffel LM. Associations of diabetes self-management characteristics, HbA1c, and psychosocial outcomes with depressive symptoms in a contemporary sample of adolescents with type 1 diabetes. J Diabetes Complications. 2021 Mar;35(3):107838. doi: 10.1016/j.jdiacomp.2020.107838. Epub 2021 Jan 6.
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 (실제)
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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