The Health Log: A Randomized Clinical Trial

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Other: Health Log

• Registration Number: NCT01913080
• Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-07-30
• Study First Submitted QC: 2013-07-30
• Study First Posted: 2013-07-31
• Study Start: 2013-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health Log	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.

Primary Outcome Measures

Name	Time	Method
Change in Self-Efficacy	baseline and 12 months	assessed using the Arthritis Self-Efficacy Scale

Secondary Outcome Measures

Name	Time	Method
Change in the statement "How satisfied are you that your concerns were addressed during your clinic visit today"	baseline and 12 months	assessed using the VAS scale 10-100
Change in satisfaction with the doctor's visit	baseline and 12 months	assessed using the VAS scale 10-100

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States