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Completed

NCT Number: NCT01913080

The Health Log: A Randomized Clinical Trial

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health Log

Other

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.

Primary outcomes

  1. Change in Self-Efficacy

    Time frame: baseline and 12 months

    assessed using the Arthritis Self-Efficacy Scale

Secondary outcomes

  1. Change in satisfaction with the doctor's visit

    Time frame: baseline and 12 months

    assessed using the VAS scale 10-100

  2. Change in the statement "How satisfied are you that your concerns were addressed during your clinic visit today"

    Time frame: baseline and 12 months

    assessed using the VAS scale 10-100

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Abbott

Registry information

Official study title

The Use of a Health Management Tool in a Clinic Setting to Improve Self-Efficacy in Rheumatoid Arthritis Patients: a Randomized Clinical Trial.

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 31, 2013
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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