- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04226027
Dynamically Tailored Behavioral Interventions in Diabetes
Dynamically Tailoring Interventions for Problem-Solving in Diabetes Self-Management Using Self-Monitoring Data - a Randomized Controlled Trial (RCT)
연구 개요
상세 설명
One of the main difficulties in managing diabetes is that each affected individual requires personally tailored combination of diet, exercise, and medication to effectively control their blood sugar. Rather than strictly following a doctor's prescription, individuals need to carefully examine their lifestyle choices and their impact on their health. Independent learning, experimentation and problem solving become of great importance. However, they can be challenging for individuals with diabetes. In this project, the investigators will refine and evaluate a novel intervention for diabetes self-management that uses computational analysis of self-monitoring data to help individuals with type 2 diabetes identify what daily activities, including consumption of meals, physical activity, and sleep, have impact on blood glucose levels, and suggest modifications to these daily activities to improve blood glucose levels.
Growing evidence highlights significant differences in glycemic function and cultural, social, and economical circumstances of individuals with type 2 diabetes (T2DM) that impact their self-management. Precision medicine strives to personalize medical treatment to an individual's genetic makeup, computationally discovered clinical phenotypes and lifestyle. Studies showed the benefits of tailoring not only medical treatment, but also behavioral interventions. Yet, currently, personalization of self-management in T2DM requires each individual to engage in discovery, reflection, and problem-solving-critical but cognitively demanding activities-or to rely on their healthcare providers. Both of these may present considerable barriers to individuals from medically under-served low income communities. Mobile health (mHealth) solutions in T2DM bring promise of reaching wider populations in need of self-management; however, few such solutions provide assistance with personalizing self-management behaviors. Ongoing efforts on personalizing behavioral interventions outside of T2DM focus on tailoring behavior modification techniques to individuals' psycho-social characteristics, such as self-efficacy ), and tailoring delivery of intervention to individuals' context rather than on personalizing self-management strategies.
The ongoing focus of this research is on developing informatics interventions for diabetes self-management, with a specific focus on discovery with self-monitoring data and on problem-solving for improving glycemic control. In the proposed research the investigators introduce T2.coach, an mHealth intervention that uses computational analysis of self-monitoring data to identify behavioral patterns associated with poor glycemic control and formulate personalized behavioral goals for changing problematic behaviors. This study will evaluate T2.coach's efficacy in a two-arm RCT with stratified randomization conducted with Clinical Directors Network (CDN), a well-recognized primary care practice-based research network (PBRN) of Federally Qualified Health Centers (FQHCs), and Agency for Healthcare Research and Quality (AHRQ)-designated Center of Excellence (P30) for Practice-based Research and Learning.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
New York
-
New York, New York, 미국, 10032
- 모병
- Columbia University Irving Medical Center
-
연락하다:
- Olena Mamykina, PhD
- 전화번호: 212-305-3923
- 이메일: om2196@cumc.columbia.edu
-
New York, New York, 미국, 10018
- 모병
- Clinical Directors Network
-
연락하다:
- Andrea Cassells, MPH
- 전화번호: 212-382-0699
- 이메일: acass@cdnetwork.org
-
부수사관:
- Andrea Cassells, MPH
-
수석 연구원:
- Jonathan Tobin, PhD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patient of the health center for ≥ 6 months and a diagnosis of T2DM
- HbA1c ≥ 8.0,
- Aged 18 to 65 years
- Attends diabetes education program at the health center
- Owns a basic mobile phone
- Proficient in either English or Spanish
Exclusion Criteria:
- Pregnant
- Presence of severe cognitive impairment (recorded in patient chart),
- Existence of other serious illnesses (e.g. cancer diagnosis with active treatment, advanced stage heart failure, dialysis, multiple sclerosis, advanced retinopathy, recorded in patient chart),
- Plans for leaving the FQHC in the next 12 months,
- Participation in the previous trial of diabetes self-management technologies
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: T2.coach
Participants receive standard care (diabetes self-management education provided by their Federally Qualified Community Health Center) and are asked to use T2.coach for 6 months.
|
T2.coach is a smartphone app for low-burden capture of diet and blood glucose (BG) levels and for reviewing past records, integrated with FitBit for captured of physical activity and sleep.
All captured data are sent to the computational inference engine that uses machine learning methods and expert system to formulate personalized behavioral goals.
Examples of behavioral goals include the following: "For high carbohydrate breakfasts, reduce your carbs to be about 1 carb choice.
Examples of 1 carb choice are 1 slice of whole wheat toast, 1 cup of oatmeal, or 1 apple."
The T2.coach chatbot companion uses text messages to help individuals set goals that are consistent with evidence based guidelines for diabetes self-management, inferences on data captured with T2.coach, and their own preferences, as well as send individuals goal reminders and prompts for reflection on goal achievement.
|
간섭 없음: Control
Participants receive standard care (diabetes self-management education provided by their Federally Qualified Community Health Center).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in HbA1c value
기간: Baseline, 6 months, 12 months
|
Hemoglobin A1c
|
Baseline, 6 months, 12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
DPSI Score
기간: Baseline, 6 months, 12 months
|
Diabetes Problem-Solving Inventory (DPSI) is a 9-item, open-ended questionnaire.
Answers are coded on a Likert 5-point scale (1-very poor strategy; 5-excellent strategy).
The final score ranges from 1 (lowest) to 5 (highest) and an overall score ≤3 indicates poor diabetes problem solving, so a higher score indicates a better outcome.
|
Baseline, 6 months, 12 months
|
SCA-I Score
기간: Baseline, 6 months, 12 months
|
Diabetes Self-Care Inventory (SCA-I) is a 15-item 5-point Likert scale (1-never engage; 5-always engage) for measuring different aspects of diabetes self-care.
The final score ranges from 1 (lowest) to 5 (highest) with a higher score indicating better self-care (better outcome).
|
Baseline, 6 months, 12 months
|
DSES Score
기간: Baseline, 6 months, 12 months
|
Diabetes Self-Efficacy Scale (DSES) is a 15-item 10-point Likert scale (1-not at all confident; 4-totally confident) that measures the belief that one can self-manage one's own health, adapted to diabetes.
The final score ranges from 1 (lowest) to 4 (highest) with a lower score indicating poor self-efficacy (worse outcome).
|
Baseline, 6 months, 12 months
|
PAID Score
기간: Baseline, 6 months, 12 months
|
Problem Areas in Diabetes (PAID) is a 20-item 5-point Likert scale (0-not a problem; 4-very serious problem) that measures the emotional aspect of living with diabetes.
The final score ranges from 0 (lowest) to 80 (highest), with a higher score indicating greater emotional discomfort (worse outcome).
|
Baseline, 6 months, 12 months
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Olena Mamykina, PhD, Columbia University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- AAAS5528
- R01DK113189 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
제2형 당뇨병에 대한 임상 시험
-
Postgraduate Institute of Medical Education and...완전한
-
Chong Kun Dang Pharmaceutical완전한
-
Sohag Universitysohag university hospital모병
-
Centre hospitalier de l'Université de Montréal...Maisonneuve-Rosemont Hospital모병Boston Keratoprosthesis Type I의 각막 용해캐나다
-
Rhythm Pharmaceuticals, Inc.완전한Pro-opiomelanocortin(POMC), Proprotein Convertase Subtilisin/Kexin Type 1(PCSK1) 및 Leptin 수용체(LepR) 유전자 돌연변이미국, 이스라엘, 캐나다, 독일, 그리스, 이탈리아, 포르투갈
-
Xiang XieXinjiang Medical University아직 모집하지 않음암 | 죽상동맥경화성 심혈관 질환 | ASCVD | Proprotein Convertase Subtilisin/Kexin Type 9 억제제
-
Jin-Hee AhnAsan Medical Center알려지지 않은HER-2 유전자 증폭 | HER-2 단백질 과발현
-
University of Bologna완전한
-
Tianjin Chest Hospital모병급성관상동맥증후군 | Proprotein Convertase Subtilisin/Kexin Type 9 억제제중국
T2.coach에 대한 임상 시험
-
Oregon Health and Science UniversityUniversity of Missouri-Columbia; Vanderbilt University Medical Center모병
-
University of RochesterUniversity of Pennsylvania; University of Michigan; Zhejiang University완전한
-
Bryan AllenNational Cancer Institute (NCI); Holden Comprehensive Cancer Center모병
-
University GhentFund for Scientific Research, Flanders, Belgium완전한
-
Pfizer's Upjohn has merged with Mylan to form Viatris...완전한