Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatment health log
Sponsor Brigham and Women's Hospital
Collaborator Abbott
Start date September 2013
End date September 2016
Trial size 150 participants
Trial identifier NCT01913080, 2013P000973

Summary

The goal of the present study is to determine if a health management tool improves self-efficacy, satisfaction with the doctor's visit, and agreement of the statement "How satisfied are you that your concerns were addressed during your clinic visit today" over time.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose health services research
Arm
(Active Comparator)
Patients who have a billing diagnosis RA (714.0)or seronegative inflammatory arthritis who are enrolled in the Brigham and Women's Rheumatoid Arthritis Sequential Study (BRASS)will be given the Health Log health management tool.
health log
The Health Log consists of a permanent booklet and a refillable health log version that is filled out before each doctor's appointment. The permanent booklet has areas to record: Personal information and emergency contact(s) Physician names and contact information Insurance information Medications, vitamins and supplements Surgeries Health history The booklet also includes suggested questions you may want to ask your Rheumatologist about medications, lifestyle, or future/status. The refillable health log includes questions about pain, fatigue,overall status from the Multi-Dimensional Health Assessment Questionnaire (MDHAQ), and a modified Arthritic Pain and Joint Evaluation. It also has space to write questions for the doctor's visit and prescription refills needed.
(No Intervention)
Controls will be BRASS patients who continue to receive regular care and are also given a pill box instead of the Health Log health management tool.

Primary Outcomes

Measure
Change in Self-Efficacy
time frame: baseline and 12 months

Secondary Outcomes

Measure
Change in satisfaction with the doctor's visit
time frame: baseline and 12 months
Change in the statement "How satisfied are you that your concerns were addressed during your clinic visit today"
time frame: baseline and 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - billing diagnosis of rheumatoid arthritis (714.0) or seronegative inflammatory arthritis and a member of the BRASS study at Brigham and Women's Hospital Exclusion Criteria: - less than 18 years of age

Additional Information

Official title The Use of a Health Management Tool in a Clinic Setting to Improve Self-Efficacy in Rheumatoid Arthritis Patients: a Randomized Clinical Trial.
Principal investigator Nancy A Shadick, MD, MPH
Description The Patient-Centered Outcomes Initiative (PACO) was developed at Brigham and Women's Hospital (BWH) to create a replicable model of patient-centered care that will improve treatment for patients with rheumatoid arthritis (RA) and lead to improved outcomes. This work began with focus groups of RA patients to determine which changes or programs they felt were needed. Among the suggestions was a health management tool to improve doctor-patient communication. The Patient Advisory Committee (PAC), a part of PACO which grew out of the focus groups, worked to develop the current Health Log. It consists of a permanent booklet and a refillable health log version that is filled out before each doctor's appointment. Health management tools have also been developed for patients with other chronic conditions. Dr. Paul Fortin of the University Health Network developed the Lupus Health Passport, which helps patients keep track of their health and also has information about lupus as well as prevention of coronary artery disease (CAD) and osteoporosis. However, although these health management tools have been well received, they have not been studied to see if they improve self-efficacy. We would like to determine if the use of the Health Log improves self-efficacy in RA patients over time. Specifically we will be looking to: 1. Determine if this health management tool improves self-efficacy over time with use, as measured by the Self-Efficacy Other Symptoms Scale of the Arthritis Self-Efficacy Questionnaire. 2. Determine if this health management tool improves satisfaction with the doctor's visit as measured by a VAS scale 10-100. 3. Determine if this health management tool improves agreement with the statement "How satisfied are you that your concerns were addressed during your clinic visit today", as measured by a VAS scale 10-100.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.