The Health Log: A Randomized Clinical Trial
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
|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.|
- Change in Self-Efficacy [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]assessed using the Arthritis Self-Efficacy Scale
- Change in satisfaction with the doctor's visit [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]assessed using the VAS scale 10-100
- Change in the statement "How satisfied are you that your concerns were addressed during your clinic visit today" [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]assessed using the VAS scale 10-100
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Health Log
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.
Other: 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:
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: Control Pill Box
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.
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:
- 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.
- Determine if this health management tool improves satisfaction with the doctor's visit as measured by a VAS scale 10-100.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01913080
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Nancy A Shadick, MD, MPH||Brigham and Women's Hospital|