T2D를 위한 원격의료 강화 파일럿 연구
복합 제2형 당뇨병이 있는 성인을 위한 원격 의료 관리 제공을 강화하는 파일럿 연구
The goal of this pilot clinical trial is to assess feasibility of an intervention to deliver comprehensive, high-quality diabetes care through telemedicine among adults with type 2 diabetes who use insulin and have multiple chronic health conditions. The main question it aims to answer is:
Is an enhanced telemedicine intervention for type 2 diabetes compared to usual telemedicine care feasible?
Researchers will compare the enhanced telemedicine intervention to usual telemedicine care to see if there are differences in patient satisfaction or preliminary clinical outcomes.
Participants will complete 2-3 telemedicine diabetes care visits over approximately 6 months, as well as complete survey measures with each diabetes care visit. Patients in the intervention group will also receive additional support, including pre-visit preparation phone calls, diabetes self-management education and support aligned with their visits, and post-visit follow-up calls.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
This pilot study will compare an intervention to deliver high-quality diabetes care through telemedicine for adults with type 2 diabetes who have additional chronic health conditions and use insulin with usual telemedicine care. The investigators will assess feasibility, patient satisfaction, and preliminary clinical outcomes.
Fifty adults will be recruited from primary care practices. Once patients are confirmed eligible, they will be consented and enrolled. Patients will be randomized to the intervention arm or usual telemedicine care, stratified by age (above or below 65 years) and rurality, as these factors are associated with technological literacy and broadband access, which may impact telemedicine use and outcomes. Both groups will complete baseline survey measures and baseline clinical data will be collected via chart review. As this is a pragmatic pilot trial, intervention components will be delivered by usual clinical providers and staff for the intervention group. The telemedicine care intervention will include 2-3 synchronous visits with endocrinology providers over 6 months plus additional visits with multidisciplinary providers on an individualized basis. Telemedicine care will proceed as usual for the control group.
The investigators will focus pilot trial outcomes on standard metrics to assess feasibility for a future large trial. The investigators will also measure preliminary clinical outcomes.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, 미국, 15213
- University of Pittsburgh
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- adults 18 years or older
- Diagnosis of type 2 diabetes based on abbreviated ICD-10 code E11.X in medical record or self-report
- HbA1c greater than or equal to 8% based on most recent value at time of recruitment
- Patients must own or have access to a smart phone, tablet, or home computer with data or internet connection that allows access to video-based visits
- Patient must use insulin
- Patients must have >2 comorbid chronic health conditions
- Be able to provide informed consent
- Reside in Pennsylvania
Exclusion criteria:
-
Age over 80 based on date of birth in electronic medical record
-
Visit with an endocrinologist in the prior 1 years
-
Dementia, ESRD, malignancy based on abbreviated ICD-10 codes below in medical record or self-report of associated condition
- Dementia: A81.0x, F01.5x, F02.8x, F03.9x, F10.27, F10.97, F13.27, F13.97, F18.97, F19.17, F19.27, F19.97, G30.x, G31.0x, G31.1, G31.83, G31.85
- Malignancy, except non-melanoma skin cancer: C00.x-C14.x, C15.x-C26.x, C3x.xx, C40.xx-C41.x, C43.x, C4A.xx, C45.x-C49.xx, C50.xxx, C51.x-C58, C60.x-C63.x, C64.x- C68.x, C69.xx-C72.x, C73-C76.x, C7A.xx, C80.xx-C96.x (except C90.x1, C91.x1, C92.x1, C93.x1, C94.x1, C95.x1)
- ESRD N18.6
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Type 1, gestational, or other diabetes based on abbreviated ICD-10 codes below in medical record or self-report of associated condition
- Type 1 diabetes: E10.X
- Gestational diabetes: O24.X, E08.X
- Other diabetes: E09.X, E13.2
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Pregnant or planning to become pregnant in next 6 months
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Currently enrolled in another diabetes management intervention study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Enhanced Telemedicine Care
Specialty care for type 2 diabetes delivered via telemedicine by an endocrinologist, with additional multidisciplinary support from the diabetes care team. |
Telemedicine-based endocrinology specialty care for type 2 diabetes with multidisciplinary diabetes care team support including pre-visit preparation, in-visit support and self-management education, and post-visit follow-up. |
|
활성 비교기: Usual Care
Specialty care for type 2 diabetes delivered via telemedicine by an endocrinologist following usual clinical care protocols. |
Routine telemedicine-based endocrinology specialty care for type 2 diabetes, generally consisting of synchronous virtual visit with an endocrinologist and additional support including self-management education on an individualized basis. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Recruitment percentage
기간: 12 months
|
Percent of eligible patients approached who are enrolled |
12 months
|
|
Loss to follow up
기간: 6 months
|
Percent of enrolled patients who do not complete study, defined as not completing at least 2 study visits and associated surveys |
6 months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Recruitment rate
기간: 12 months
|
Number of patients recruited per month |
12 months
|
|
Eligibility percentage
기간: 12 months
|
Percent of patients approached who are eligible |
12 months
|
|
Visit attendance
기간: 6 months
|
Percent of scheduled visits completed per patient |
6 months
|
|
Number of between-visit contacts
기간: 6 months
|
Number of successful and attempted patient contacts by clinicians between visits per patient |
6 months
|
|
Blood glucose data availability
기간: 6 months
|
Number of telemedicine visits with blood glucose data available at visit per patient |
6 months
|
|
Patient satisfaction with telemedicine diabetes care
기간: 6 months
|
Percent of patients reporting satisfied or very satisfied on a 5-point Likert scale ranging from 1 "strongly disagree" to 5 "strongly agree" with the statement "Overall, I am satisfied with the quality of service being provided via telemedicine" with higher scores indicating greater satisfaction |
6 months
|
|
Diabetes Treatment Satisfaction Questionnaire-static version
기간: Baseline
|
Total score of 8-item measure of global satisfaction with diabetes treatment regimen. The static version will be used at baseline. Items 1, 4, 5, 6, 7 & 8 are summed to produce a Treatment Satisfaction score (range:0 to 36). The higher the score, the greater the satisfaction with treatment. 'Perceived frequency of hyperglycaemia' (item 2) & 'Perceived frequency of hypoglycaemia' (item 3): Both rated: 6 ('most of the time') to 0 ('none of the time'). Here, lower scores indicate blood glucose levels closer to the ideal. Higher scores indicate problems. |
Baseline
|
|
Diabetes Treatment Satisfaction Questionnaire-change version
기간: 6 months
|
Total score of 8-item measure of global satisfaction with diabetes treatment regimen. The change version will be used at 6 months.Items 1, 4, 5, 6, 7 and 8 are summed to produce a Treatment Satisfaction (change) score (range: +18 to -18). The higher the score, the greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 represents no change. Two remaining items ('Perceived change in frequency of hyperglycaemia' (item 2) and 'Perceived change in frequency of hypoglycaemia' (item 3)) are treated individually: Both rated: +3 ('much more of the time now') to -3 ('much less of the time now'). Here, negative scores indicate fewer problems with blood glucose levels. Positive scores indicate more problems than before. |
6 months
|
|
T2D Diabetes Distress Core Scale
기간: Baseline and 6 months
|
Change in total score of 8-item measure of diabetes-related distress over prior month from baseline to 6 months. The Diabetes Distress Core scale is scored by averaging the value for each item, ranked from 1 to 5 scale (score range 1-5), with higher scores indicating more distress. |
Baseline and 6 months
|
|
HbA1c change
기간: Baseline and 6 months
|
Change in glycemic control from baseline to 6 months |
Baseline and 6 months
|
|
Prescription of guideline-based GLP-1 receptor agonist
기간: Baseline and 6 months
|
Number of patients with indications for GLP-1 receptor agonist therapy who are prescribed the indicated medication |
Baseline and 6 months
|
|
Prescription of guideline-based SGLT2 inhibitor
기간: Baseline and 6 months
|
Number of patients with indications for SGLT2 inhibitor therapy who are prescribed the indicated medication |
Baseline and 6 months
|
|
Retinal examination
기간: 6 months
|
Number of patients with documentation of retinal examination performed in last year in medical record |
6 months
|
|
Urine protein testing
기간: 6 months
|
Number of patients with documentation of urine protein testing performed in last year in medical record |
6 months
|
|
Immunization-pneumococcal
기간: 6 months
|
Number of patients with documentation of pneumococcal vaccination in medical record |
6 months
|
|
Immunization-influenza
기간: 6 months
|
Number of patients with documentation of influenza vaccination in medical record |
6 months
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Margaret Zupa, MDMS, University of Pittsburgh
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
기타 연구 ID 번호
- STUDY24060062
- K23DK135794 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
A deidentified dataset including limited demographic, encounter, laboratory result, clinical observations, medication orders, care utilization, and survey (intervention satisfaction, treatment satisfaction, diabetes distress) data will be created. To protect research participant identities, datasets will not include any potentially identifying participant information.
IPD 공유 기간
The data will become available no later than 12 months and ending 36 months after the primary trial results are published.
IPD 공유 액세스 기준
No access will be granted until the requesting investigator vetting process is completed including an IRB-approved protocol and data use agreement with the University of Pittsburgh.The data that may be shared includes: de-identified participant data, tables, figures, appendices, analysis plan, and protocol.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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