The Health Log: A Randomized Clinical Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Brigham and Women's Hospital
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Nancy Shadick, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01913080
First received: July 30, 2013
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Rheumatoid Arthritis
Other: Health Log

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Change in Self-Efficacy [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    assessed using the Arthritis Self-Efficacy Scale


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 150
Study Start Date: September 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:

  • 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.

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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01913080

Contacts
Contact: Nancy A Shadick, MD, MPH 617-732-5266 nshadick@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Nancy A Shadick, MD, MPH    617-732-5266    nshadick@partners.org   
Sponsors and Collaborators
Brigham and Women's Hospital
Abbott
Investigators
Principal Investigator: Nancy A Shadick, MD, MPH Brigham and Women's Hospital
  More Information

Additional Information:
Publications:

Responsible Party: Nancy Shadick, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01913080     History of Changes
Other Study ID Numbers: 2013P000973
Study First Received: July 30, 2013
Last Updated: January 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
health management

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014