- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07925710
Osteoarthritis Care Tools for Primary Care Providers in Family Medicine and Geriatrics Clinics
OACareTools PLUS (OACareTools Primary Care-Led Usability & Scalability Study): Aim 3 Implementation and Evaluation
The purpose of this study is to test the implementation of OACareTools+, a program designed to help healthcare providers connect adults with arthritis to physical activity programs. OACareTools+ includes provider training, patient resources, and tools to make referrals easier. The goal is to increase awareness of programs like Walk With Ease and help more people with arthritis participate in them.
연구 개요
상세 설명
Participants will be clinicians (n= 165) in geriatrics and family medicine clinics and a subset of patients (n=30). The study team will deliver education and resources to providers in a training session about Walk With Ease. After the provider training, providers will use the study resources to refer patients with arthritis to Walk With Ease. Healthcare provider participants will complete surveys after their first referral and at the end of the study (12-months). Patient participants who are referred to Walk With Ease through the OACareTools+ intervention will be invited to participate in interviews about their experience (6-weeks) with the referral process. Primary endpoints of the study will be 1) number of healthcare providers that referred patients to Walk With Ease 2) number of Walk With Ease patient participants 3) healthcare provider acceptability and feasibility 4) patient acceptability of the intervention.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Katie Huffman
- 전화번호: 919-962-5145
- 이메일: katie_huffman@med.unc.edu
연구 장소
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599
- UNC Thurston Arthritis Research Center
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연락하다:
- Katie Huffman
- 전화번호: 919-962-5145
- 이메일: katie_huffman@med.unc.edu
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Healthcare provider participants: currently a healthcare provider or staff person in the UNC study clinics (Geriatrics and Family Medicine)
- Patient participants: 18 years or older; received a referral to Walk With Ease from a provider at a UNC study clinic or used clinic flyers to register for Walk with Ease and agreed to participate in the phone interview on the post-Walk With Ease evaluation form
Exclusion Criteria:
- Both: non-English speaking
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Healthcare providers
Healthcare providers will receive the intervention, OACareTools+, which involves a training session on, patient resources about, and provider referral to Walk With Ease. |
OACareTools+ is a healthcare provider intervention that combines healthcare provider education, customized patient and clinical resources, and technical support from a national organization to facilitate provider counseling on and referral to as well as patient engagement in Walk With Ease. There are 2 main parts to this intervention: 1) Healthcare provider education: The study team will deliver the provider education and resources (including information about Walk With Ease and the established referral process/smartphrase) in live and recorded presentations and in follow-up emails. 2) Implementation: Providers will use the resources to briefly counsel patients about physical activity and Walk With Ease and use the smartphrase to refer patients to Walk With Ease. Patients will register for and participate in the online Walk With Ease program. Patients and providers can seek assistance from the national organization as needed during these processes.
다른 이름들:
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실험적: Patients
A subset of patients who are referred through OACareTools+ to Walk With Ease will provide feedback on their experience with the referral process to Walk With Ease. |
OACareTools+ is a healthcare provider intervention that combines healthcare provider education, customized patient and clinical resources, and technical support from a national organization to facilitate provider counseling on and referral to as well as patient engagement in Walk With Ease. There are 2 main parts to this intervention: 1) Healthcare provider education: The study team will deliver the provider education and resources (including information about Walk With Ease and the established referral process/smartphrase) in live and recorded presentations and in follow-up emails. 2) Implementation: Providers will use the resources to briefly counsel patients about physical activity and Walk With Ease and use the smartphrase to refer patients to Walk With Ease. Patients will register for and participate in the online Walk With Ease program. Patients and providers can seek assistance from the national organization as needed during these processes.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Healthcare provider acceptability
기간: Measure collected up to 2 months after provider's first referral
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The Acceptability of Intervention Measure is a measure of implementation outcomes, including 4 items ranked on a Likert scale of 1 (completely disagree) to 5 (completely agree), with a summed total ranging from 4-20 where higher scores indicate greater acceptability; measured via electronic survey. |
Measure collected up to 2 months after provider's first referral
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Healthcare provider feasibility
기간: Measure collected up to 2 months after provider's first referral
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The Feasibility of Intervention Measure is a measure of implementation outcomes, including 4 items ranked on a Likert scale of 1 (completely disagree) to 5 (completely agree), with a summed total ranging from 4-20 where higher scores indicate greater feasibility; measured via electronic survey. |
Measure collected up to 2 months after provider's first referral
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Patient acceptability
기간: 6-weeks post- Walk With Ease registration
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The Acceptability of Intervention Measure is a measure of implementation outcomes, including 4 items ranked on a Likert scale of 1 (completely disagree) to 5 (completely agree), with a summed total ranging from 4-20 where higher scores indicate greater acceptability; measured via telephone interview. |
6-weeks post- Walk With Ease registration
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Patient usefulness: clinician referral to Walk With Ease
기간: 6-weeks post- Walk With Ease registration
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During a phone interview, patients will be asked, "How helpful was it to talk with healthcare provider about physical activity and Walk With Ease?" They will be asked to use a scale, 0-10, where 0 is not helpful at all and 10 is extremely helpful. Higher scores indicate greater levels of helpfulness. |
6-weeks post- Walk With Ease registration
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Number of healthcare providers who referred patients
기간: 12 months
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Healthcare providers in the study clinics who refer patients to the Walk With Ease program using the study referral process and resources |
12 months
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Number of patients who registered for Walk with Ease
기간: 12 months
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Patients from the study clinics who register in the Walk With Ease program |
12 months
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Patient usefulness: educational resources
기간: 6-weeks post-Walk with Ease registration
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During a phone interview, patients will be asked, "How helpful were the education materials given to you by your healthcare provider?" They will be asked to use a scale, 0-10, where 0 is not helpful at all and 10 is extremely helpful. Higher scores indicate greater levels of helpfulness. |
6-weeks post-Walk with Ease registration
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공동 작업자 및 조사자
수사관
- 수석 연구원: Leigh Callahan, PhD, UNC Thurston Arthritis Research Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 26-2715
- 1U48DP006837-01 (미국 NIH 보조금/계약)
- 1 U48DP006837-01-03 (기타 보조금/기금 번호: Centers for Disease Control and Prevention)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Deidentified individual data that support the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC. Data collected include: pre/post walking program assessments, referral count, patient engagement metrics, arthritis outcomes, satisfaction (provider and patient). Qualitative data will be available in the form of a summary.
IPD 공유 기간
Beginning 9 and continuing for 36 months following publication.
IPD 공유 액세스 기준
Approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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