The Health Log: A Randomized Clinical Trial

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01913080
Study type	Interventional
Source	Brigham and Women's Hospital
Contact
Status	Completed
Phase	N/A
Start date	September 2013
Completion date	September 2016

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.