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The Health Log: A Randomized Clinical Trial

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Mass General Brigham

Status

Completed

Conditions

Rheumatoid Arthritis

Treatments

Other: Health Log

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01913080
2013P000973

Details and patient eligibility

About

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.

Full 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.

Enrollment

67 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

67 participants in 2 patient groups

Health Log
Active Comparator group
Description:
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.
Treatment:
Other: Health Log
Control Pill Box
No Intervention group
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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