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CompletedNCT01913080Updated Feb 1, 2017

The Health Log: A Randomized Clinical Trial

An interventional study of Health Log in Rheumatoid Arthritis, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-01.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
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Conditions studied

  • Rheumatoid Arthritis

Keywords

  • health management
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 67 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • less than 18 years of age
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
67 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • OtherHealth 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.

06

What researchers measure

Primary outcomes

  1. Change in Self-Efficacy

    assessed using the Arthritis Self-Efficacy Scale

    Time frame: baseline and 12 months

Secondary outcomes

  1. Change in satisfaction with the doctor's visit

    assessed using the VAS scale 10-100

    Time frame: baseline and 12 months

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

    assessed using the VAS scale 10-100

    Time frame: baseline and 12 months

07

Study locations

1 site
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
08

References and documents

Publications

  • Linos A, Worthington JW, O'Fallon WM, Kurland LT. The epidemiology of rheumatoid arthritis in Rochester, Minnesota: a study of incidence, prevalence, and mortality. Am J Epidemiol. 1980 Jan;111(1):87-98. doi: 10.1093/oxfordjournals.aje.a112878. PubMed 7352462 ↗
  • Harris, E.D., Rheumatoid arthritis. 1997, Philadelphia: Saunders. xxiii, 433.
  • Pincus T, Callahan LF, Sale WG, Brooks AL, Payne LE, Vaughn WK. Severe functional declines, work disability, and increased mortality in seventy-five rheumatoid arthritis patients studied over nine years. Arthritis Rheum. 1984 Aug;27(8):864-72. doi: 10.1002/art.1780270805. PubMed 6431998 ↗
  • Sherrer YS, Bloch DA, Mitchell DM, Young DY, Fries JF. The development of disability in rheumatoid arthritis. Arthritis Rheum. 1986 Apr;29(4):494-500. doi: 10.1002/art.1780290406. PubMed 3707627 ↗
  • Callahan LF, Brooks RH, Summey JA, Pincus T. Quantitative pain assessment for routine care of rheumatoid arthritis patients, using a pain scale based on activities of daily living and a visual analog pain scale. Arthritis Rheum. 1987 Jun;30(6):630-6. doi: 10.1002/art.1780300605. PubMed 3606681 ↗
  • Yelin E, Meenan R, Nevitt M, Epstein W. Work disability in rheumatoid arthritis: effects of disease, social, and work factors. Ann Intern Med. 1980 Oct;93(4):551-6. doi: 10.7326/0003-4819-93-4-551. PubMed 7436187 ↗
  • Meenan RF, Yelin EH, Henke CJ, Curtis DL, Epstein WV. The costs of rheumatoid arthritis. A patient-oriented study of chronic disease costs. Arthritis Rheum. 1978 Sep-Oct;21(7):827-33. doi: 10.1002/art.1780210714. PubMed 100122 ↗
  • Pincus T, Brooks RH, Callahan LF. Prediction of long-term mortality in patients with rheumatoid arthritis according to simple questionnaire and joint count measures. Ann Intern Med. 1994 Jan 1;120(1):26-34. doi: 10.7326/0003-4819-120-1-199401010-00005. PubMed 8250453 ↗
  • Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989 Jan;32(1):37-44. doi: 10.1002/anr.1780320107. PubMed 2912463 ↗
  • Ware JE, Kosinski M, Keller SD. SF-12: How to Score the SF-12 Physical and Mental Health Summary Scales. 2nd ed. Boston, MA: The Health Institute, New England Medical Center; 1995.
  • Wolfe F, Michaud K, Pincus T. Development and validation of the health assessment questionnaire II: a revised version of the health assessment questionnaire. Arthritis Rheum. 2004 Oct;50(10):3296-305. doi: 10.1002/art.20549. PubMed 15476213 ↗
  • Prevoo ML, van 't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum. 1995 Jan;38(1):44-8. doi: 10.1002/art.1780380107. PubMed 7818570 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01913080
Lead sponsor
Brigham and Women's Hospital
Collaborators
Abbott
Responsible party
Nancy Shadick (Principal Investigator, Brigham and Women's Hospital) — Principal investigator
First posted
Jul 31, 2013
Start date
Sep 2013
Primary completion
Sep 2016
Completion
Sep 2016
Last update
Feb 1, 2017

Study contacts

Nancy A Shadick, MD, MPH
principal investigator · Brigham and Women's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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