- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02540044
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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British Columbia
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Richmond, British Columbia, Canada, V6X2C7
- Recrutement
- Arthritis Research Canada
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Contact:
- Jasmina Geldman, MS
- Numéro de téléphone: 604-207-4007
- E-mail: jgeldman@arthritisresearch.ca
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Contact:
- Navi Grewal, MS
- Numéro de téléphone: 604-207-4053
- E-mail: ngrewal@arthritisresearch.ca
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Chercheur principal:
- Linda Li, PT,PhD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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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.
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Comparateur actif: 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.
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The Arthritis Society Consumer guide pdf.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Decisional Conflict Scale
Délai: Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1)
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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.
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Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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MeiQ
Délai: Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1, and at month 2)
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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.
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Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1, and at month 2)
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Partners in Health Scale
Délai: Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1, and at month 2)
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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.
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Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1, and at month 2)
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Health Resource Utilization
Délai: Change measure (baseline score compared to after using the ANSWER-2 at month 2)
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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.
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Change measure (baseline score compared to after using the ANSWER-2 at month 2)
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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CollaboRATE Scale
Délai: Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1)
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a 3-item measure of the shared decision making process
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Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1)
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Linda Li, PhD, Professor
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- H15-02046
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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