Supporting Patient Care With Electronic Resource (SuPER) (SuPER)
Supporting Patient Care With Electronic Resource (SuPER): Efficacy of an Online Decision Aid for Patients Considering Biologic Therapy for Rheumatoid Arthritis
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
British Columbia
-
Richmond、British Columbia、カナダ、V6X2C7
- 募集
- Arthritis Research Canada
-
コンタクト:
- Jasmina Geldman, MS
- 電話番号:604-207-4007
- メール:jgeldman@arthritisresearch.ca
-
コンタクト:
- Navi Grewal, MS
- 電話番号:604-207-4053
- メール:ngrewal@arthritisresearch.ca
-
主任研究者:
- Linda Li, PT,PhD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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.
|
|
アクティブコンパレータ: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.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Decisional Conflict Scale
時間枠: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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
MeiQ
時間枠: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
時間枠: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
時間枠: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)
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
CollaboRATE Scale
時間枠: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)
|
協力者と研究者
協力者
捜査官
- 主任研究者:Linda Li, PhD、Professor
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。