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Enhancing Self-Management Support in Diabetes Through Patient Engagement (EE-CTH)

2021년 2월 19일 업데이트: University of California, San Francisco

The Patient Centered Medical Home (PCMH) and the Chronic Care Model (CCM) are complementary clinical intervention frameworks that are commonly invoked to support better type 2 diabetes (T2DM) outcomes in primary care. Self-management Support (SMS) is a core component of both the PCMH and CCM, and focuses on the central role of patients in managing their illness by engaging with and adopting healthy behaviors that promote optimal clinical outcomes. Despite its recognized importance, SMS programs for diabetes continue to demonstrate limited effectiveness in the real-world of primary care.

SMS is comprised of two complementary and interactive components: (1) patient engagement (e.g., the process of eliciting and responding to patients emotions and motivations related to health behaviors), and (2) behavioral change tools (e.g., selecting specific goals, creating action plans). While several sophisticated SMS programs have been developed for T2DM, the vast majority are designed with a narrow focus on behavioral change tools, largely ignoring unique aspects of the patient context that drive and maintain health behavior. Considerable clinical research suggests that the addition of a structured, evidenced-based program of patient engagement can maximize the effectiveness of SMS programs for patients with T2DM in primary care.

To date there has been no systematic study of the degree to which fully integrating enhanced patient engagement as part of SMS will increase the initiation and maintenance of behavior change over time, and for which kinds of patients enhanced patient engagement is essential. To address this gap, the investigators will compare a state-of-the-art, evidence-based SMS behavior change tool program, called Connection to Health (CTH), with an enhanced CTH program that includes a practical, time-efficient patient engagement protocol, to create a program with an integrated and comprehensive approach to SMS, called "Enhanced Engagement CTH" (EE-CTH). The current study will directly test the added benefit of EE-CTH to CTH with regard to self-management behaviors and glycemic control in resource-limited community health centers, where vast numbers of patients with T2DM from ethnically diverse and medically vulnerable populations receive their care. The investigators will use an effectiveness-implementation hybrid design, employing the "Reach Effectiveness Adoption Implementation Maintenance" (RE-AIM) framework to test these two SMS programs for T2DM. This will provide critical information that will support dissemination and implementation of effective SMS programs in resource-limited primary care settings, serving diverse and medically vulnerable populations with much to gain from improved SMS.

연구 개요

상세 설명

This is a two-arm, 14 month pragmatic cluster randomized trial to evaluate the added benefit of EE-CTH relative to CTH for patients with T2DM in primary care.

Primary care practices (not patients) will be randomly assigned to receive and deliver CTH or EE-CTH in an innovative effectiveness-implementation hybrid design. Using the RE-AIM framework, the investigators will evaluate program effectiveness in a real world setting, while at the same time gathering information on program reach, adoption, implementation and maintenance. CTH and EE-CTH practice trainings and delivery will each follow separate and standardized protocols, with support provided to practices through staff training, ongoing supervision and case presentations, and a practice improvement team assisted by a practice facilitator to address issues of staffing and patient flow. Practice training and facilitation notes, in conjunction with feedback from patient advisory councils, will be captured and integrated to identify barriers and facilitators to the implementation process and inform dissemination efforts. Beyond the requirements of the study, practices will be permitted to use EE-CTH or CTH with other patients as wished, which will enable the investigators to document the program's reach within the practice. Patients in both study arms will receive the intervention at a minimum of two primary care appointments (baseline and follow-up between 6 and 12 months).

연구 유형

중재적

등록 (실제)

725

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • California
      • San Francisco, California, 미국, 94143
        • University of California, San Francisco

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

21년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Type 2 diabetes;
  • Diagnosed and receiving care at participating practices for at least 12 months;
  • Able to read in English or Spanish (at least 6th grade level).

Exclusion Criteria:

  • Not meeting all inclusion criteria

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Connection to Health (CTH)
CTH is a comprehensive SMS program that focuses on behavior change. CTH utilizes web-based interactive behavior change technology, based on a logic model of behavior and maintenance that is informed by social-cognitive and social ecological theories. Prior to diabetes visits with a clinician, health educator, or care manager, patients complete a pre-visit CTH assessment at their practice through a tablet computer or computer kiosk. CTH assesses multiple diabetes management behaviors (diet, physical activity, medication adherence, alcohol and tobacco use, stress, mood) using brief assessment measures, each with cut-points highlighting areas of deficit. Action planning plays a central role, through a web-based platform that allows the patient and health care team to select and set goals collaboratively.
CTH is a comprehensive SMS program that focuses on behavior change.
실험적: Enhanced Engagement Protocol for CTH (EE-CTH)
EE-CTH seamlessly integrates CTH with an efficacious, structured, motivational interview (MI)-informed protocol specifically designed to enhance patient engagement in SMS activities. Key components of MI have been incorporated into a practical and systematic engagement protocol that includes: (1) acknowledging the patient's point of view; (2) identifying and labeling the patient's ambivalence (both the good reasons for making the change and the good reasons for not making the change); (3) evaluating whether change is really worth the effort; (4) identifying, reflecting and labeling accompanying feelings and concerns about change; and (5) establishing a small and meaningful goal by the end of the encounter.
EE-CTH integrates CTH with an efficacious, structured, motivational interview (MI)-informed protocol.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
HbA1c (glycated haemoglobin)
기간: Change from baseline to follow-up (6 to 12 months)
Percentage HbA1c
Change from baseline to follow-up (6 to 12 months)
High fat food
기간: Change from baseline to follow-up (6 to 12 months)
Amount of high fat food consumed weekly adapted from the Summary of Diabetes Self-Care Activities
Change from baseline to follow-up (6 to 12 months)
Physical activity
기간: Change from baseline to follow-up (6 to 12 months)
Number of minutes of participation in physical activity from the International Physical Activity Questionnaire
Change from baseline to follow-up (6 to 12 months)
Number of days missed medications
기간: Change from baseline to follow-up (6 to 12 months)
Number of days missed missing one or more medications in the past 14 days
Change from baseline to follow-up (6 to 12 months)
Medication adherence
기간: Change from baseline to follow-up (6 to 12 months)
Frequency of reasons for missing medications.
Change from baseline to follow-up (6 to 12 months)
Fruit and vegetable intake
기간: Change from baseline to follow-up (6 to 12 months)
Number of daily fruit and vegetable servings adapted from the Summary of Diabetes Self-Care Activities
Change from baseline to follow-up (6 to 12 months)
Sugar-sweetened beverages
기간: Change from baseline to follow-up (6 to 12 months)
Number of daily sugar-sweetened beverages from the Starting the Conversation Measure
Change from baseline to follow-up (6 to 12 months)

2차 결과 측정

결과 측정
측정값 설명
기간
Health-related distress
기간: Change from baseline to follow-up (6 to 12 months)
Modified from the Diabetes Distress Scale
Change from baseline to follow-up (6 to 12 months)
Depression symptoms
기간: Change from baseline to follow-up (6 to 12 months)
Patient Health Questionnaire (PHQ8) Score
Change from baseline to follow-up (6 to 12 months)
Weight
기간: Change from baseline to follow-up (6 to 12 months)
Weight (pounds)
Change from baseline to follow-up (6 to 12 months)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Danielle M Hessler, Ph.D., University of California, San Francisco

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2016년 10월 1일

기본 완료 (실제)

2020년 12월 20일

연구 완료 (실제)

2020년 12월 20일

연구 등록 날짜

최초 제출

2016년 7월 6일

QC 기준을 충족하는 최초 제출

2016년 7월 14일

처음 게시됨 (추정)

2016년 7월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 2월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 2월 19일

마지막으로 확인됨

2021년 2월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 15-17033
  • R18DK108039-05 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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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