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Supporting Patient Care With Electronic Resource (SuPER) (SuPER)

2017년 6월 27일 업데이트: Linda Li, University of British Columbia

Supporting Patient Care With Electronic Resource (SuPER): Efficacy of an Online Decision Aid for Patients Considering Biologic Therapy for Rheumatoid Arthritis

This proof-of-concept randomized trial evaluates the effectiveness of using an on-line decision aid (ANSWER-2) in the decision making to start or switch biologic therapy in Canadian patients with rheumatoid arthritis.

연구 개요

상세 설명

The proposed project aims to improve the process of making evidence-informed treatment decisions by patients with rheumatoid arthritis (RA) and ultimately, empower patient self-management. Current RA treatment emphasizes: 1) the need for early and aggressive treatment, and 2) the use of a Treat-to-Target approach. Patients often struggle with treatment decisions, however, especially when the options have both benefits and risks. To address this challenge, the investigators have developed a new online decision aid called ANSWER-2 (ANimated, Self-serve, WEb-based, Research Tool: Version 2) for RA patients who are considering a biologic or other new therapy. A unique feature of ANSWER-2 is its ability to individualize how treatment options are presented based on the patient's preferences.

Objective: 1) To evaluate the effectiveness of ANSWER-2 in reducing patients' decisional conflict. 2) To assess the extent to which ANSWER-2 improves patients' knowledge about RA medications and confidence in managing their health. 3) To examine the experiences of patients and rheumatologists in using the ANSWER-2.

The investigators will conduct a proof-of-concept randomized controlled trial with 148 patients with RA. Eligible individuals are those: 1) with a diagnosis of RA from a rheumatologist, 2) whose rheumatologists have recommended initiating a biologic or other new therapy or switching to another agent, and 3) who have internet access. The Intervention Group will receive simple instructions to access ANSWER-2 and complete the program on their own within two days. At the end of the session, a one-page summary will be produced to help them discuss their questions, concerns, and preferred choices with their health care providers. The Control Group will receive The Arthritis Society's online education booklet "Arthritis Medications: A Consumer's Guide". Participants will complete the Decisional Conflict Scale (primary outcome) before and after the intervention (ANSWER-2 or booklet). The following secondary outcome measures will be collected at baseline, 1 month and 2 months: 1) Medication Education Impact Questionnaire (MeIQ), and 2) Partners in Health Scale (PHS). In addition, use of healthcare resources will be collected at 2 months. Participants will also be asked about their medication preferences at Month 1, as well as the shared decision making process in their last appointment, (using the 3-item CollaboRATE scale), at Month 1. Participants who received the ANSWER-2 decision aid and their rheumatologists will be invited to participate in an interview about their experience with the patient decision aid. The investigators will use analysis of variance (ANOVA) to compare between the Intervention Group and Control Group, using the baseline measure as a covariate. An iterative content analysis will be conducted for the qualitative interviews.

연구 유형

중재적

등록 (예상)

148

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

    • British Columbia
      • Richmond, British Columbia, 캐나다, V6X2C7

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

19년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • The inclusion criteria are as follows: 1) with a diagnosis of RA from a rheumatologist, 2) whose rheumatologists have recommended initiating a biologic/subsequent entry biologic or switching to another biologic agent, and 3) who have internet access and email.

Exclusion Criteria:

  • Patients who do not meet the 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: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: ANSWER-2 decision aid
The Intervention Group will receive simple instructions to access ANSWER-2 and complete the program on their own computers within two days. At the end of the session, ANSWER-2 will produce a one-page summary summarizing the participant's questions, concerns, and preferred medication option.
ANSWER-2 will consist of: 1) an Information Module that presents effectiveness and side effects of each treatment option, and 2) an interactive Value Clarification Module that guides patients to consider what matter to them the most, and the pros and cons of each treatment option. Within the Information Module, the decision support information (i.e., the benefits and harms of treatment options) will be presented in narrated text, graphics, and a series of animated patient stories demonstrating attributes required for effective communication with doctors and significant others.
활성 비교기: Control Group (TAS Consumer Guide)
The Control Group will receive the online Arthritis Medications: A Consumer's Guide, published by The Arthritis Society. It contains standard information about biologics, including an introduction of the different biologic options, dosages and side effects.
The Arthritis Society Consumer guide pdf.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Decisional Conflict Scale
기간: Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1)
The Decisional Conflict Scale (short version) measures personal perceptions of uncertainty in choosing options, factors contributing to uncertainty, and effective decision-making. It is one-dimensional and has 10 questions and three response categories (yes/no/unsure) used to compute one score.
Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1)

2차 결과 측정

결과 측정
측정값 설명
기간
MeiQ
기간: Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1, and at month 2)
The MeiQ consists of 6 subscales and a total of 29 items. MeiQ was developed and tested in three different samples of patients with rheumatic conditions on their knowledge of medications.
Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1, and at month 2)
Partners in Health Scale
기간: Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1, and at month 2)
The Partners in Health Scale is an 11-item measure, designed to assess self-efficacy, knowledge of RA and treatment, and self-management behaviours such as taking medication appropriately and adopting a healthy lifestyle.
Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1, and at month 2)
Health Resource Utilization
기간: Change measure (baseline score compared to after using the ANSWER-2 at month 2)
The HRU questionnaire was developed for both self and interviewer administration in people with arthritis and other chronic conditions. It consists of a series of open-ended questions about individuals' visits to health professionals, use of investigative tests, hospital visits, use of medications, purchases of adaptive aids, and estimable productivity loss incurred by the individual and their caregivers due to the his/her health.
Change measure (baseline score compared to after using the ANSWER-2 at month 2)

기타 결과 측정

결과 측정
측정값 설명
기간
CollaboRATE Scale
기간: Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1)
a 3-item measure of the shared decision making process
Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

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

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

2016년 1월 1일

기본 완료 (예상)

2018년 12월 1일

연구 완료 (예상)

2018년 12월 1일

연구 등록 날짜

최초 제출

2015년 9월 1일

QC 기준을 충족하는 최초 제출

2015년 9월 2일

처음 게시됨 (추정)

2015년 9월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 6월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 6월 27일

마지막으로 확인됨

2017년 6월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

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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. .

관절염, 류마티스에 대한 임상 시험

ANSWER-2 decision aid에 대한 임상 시험

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