Arthritis Health Journal Proof of Concept Study (AHJ)
27. juni 2018 opdateret af: Diane Lacaille, University of British Columbia
Proof of Concept Study of the Arthritis Health Journal, a Patient Passport for Rheumatoid Arthritis
The purpose of this study is to determine whether an online patient passport tool called the Arthritis Health Journal can assist people with rheumatoid arthritis in managing their disease.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Patient passports have been developed and used in chronic diseases, such as diabetes, to promote active involvement of patients in their care, and have led to better treatment and health outcomes.
In rheumatoid arthritis (RA), active involvement of patients in monitoring their symptoms and their disease activity may facilitate treatment according to current recommendations, which emphasize the need for aggressive treatment to suppress inflammation and for using a "Treat to Target" approach where treatment is escalated until a target is reached and is promptly modified when target is no longer met.
In this study, the investigators have developed an online tool that aims to help people with RA monitor their symptoms and their disease activity and self-manage their arthritis.
The investigators will perform a proof of concept study assessing how the Arthritis Health Journal affects consumer effectiveness, patient self-efficacy, communication with health professionals, shared decision-making, and satisfaction with medical care.
The investigators will also evaluate the feasibility and satisfaction with using the Arthritis Health Journal.
The investigators will use a stepped wedge study design, in which 50 participants will be randomized to either the intervention group (immediate use of the Arthritis Health Journal) or the control group (waitlisted for 6 months).
Due to the nature of the intervention, the study is not blinded.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
95
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
British Columbia
-
Richmond, British Columbia, Canada, V6X 2C7
- Arthritis Research Centre of Canada
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Be 18 years of age or older
- Have a diagnosis of rheumatoid arthritis
- Be under the ongoing care of a rheumatologist
- Be comfortable using a computer and online applications
- Have access to an Internet connection
- Be able to read and write English without needing a translator
Exclusion Criteria:
- Younger than 18 years of age;
- Diagnoses of arthritis other than rheumatoid arthritis
- not under the ongoing care of a rheumatologist
- not comfortable using a computer
- lack of Internet access
- inability to read and write in English without a translator
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arthritis Health Journal
Participants in this group will use the Arthritis Health Journal in the first 6 months of study.
|
|
|
Andet: Control
Participants in this group will receive a delayed intervention.
They will receive usual care for the first 6 months of study, during which time they will contribute control data, and they will use the Arthritis Health Journal in the second 6 months of study, during which time they will contribute intervention data.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-Management Behaviours
Tidsramme: 6 months
|
We will use the overall score from the Partners in Health Scale, an 11 item questionnaire based on the principles of self-management, which measures people's ability to engage in behaviours for the self-management of a chronic disease.
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-Efficacy
Tidsramme: 6 months
|
We will use the Stanford Self-Efficacy Scale to measure patient's confidence in their ability to perform certain actions to manage their disease and cope with the consequences of their disease.
Specifically we will include the "Manage Arthritis Symptoms", "Manage Disease in General", and "Communicate with Physician" subscales.
|
6 months
|
|
Consumer Effectiveness
Tidsramme: 6 months
|
We will use the Effective Consumer (EC-17) scale to measure patient's ability to deal with a chronic condition and make decisions about their health care.
We will use the global EC-17 score, as well as results to individual questions (6, 7, 9, and 13) which were selected for their relevance to our intervention.
|
6 months
|
|
Patient Satisfaction with Care
Tidsramme: 6 months
|
We will use the Patient Satisfaction Questionnaire to measure satisfaction with care and patient-physician interactions.
|
6 months
|
|
Self-Management Behaviours
Tidsramme: 6 months
|
We will measure the results of individual questions 7 to 11 from the Partners in Health Scale, which specifically measure involvement in aspects of care relevant to our intervention.
|
6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Diane Lacaille, MD MHSc, Arthritis Research Centre of Canada
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2013
Primær færdiggørelse (Faktiske)
1. januar 2015
Studieafslutning (Faktiske)
1. februar 2016
Datoer for studieregistrering
Først indsendt
10. september 2013
Først indsendt, der opfyldte QC-kriterier
12. september 2013
Først opslået (Skøn)
13. september 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. juni 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. juni 2018
Sidst verificeret
1. juni 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H12-00691
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .