Rheumatoid ArthritisNCT01913080
The Health Log: A Randomized Clinical Trial
A study testing Health Log in people with Rheumatoid Arthritis, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Health Log
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- billing diagnosis of rheumatoid arthritis (714.0) or seronegative inflammatory arthritis and a member of the BRASS study at Brigham and Women's Hospital
Who cannot join
- less than 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
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:
- 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Health Log
- Keywords
- health management
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health LogOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Health Log | Active comparator | 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. Receives: Other: Health Log |
| Control Pill Box | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-Efficacy
assessed using the Arthritis Self-Efficacy Scale
Measured: baseline and 12 months
Secondary outcomes (2)
Change in satisfaction with the doctor's visit
assessed using the VAS scale 10-100
Measured: baseline and 12 months
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
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Nancy Shadick, Brigham and Women's Hospital
- Investigators
- Nancy A Shadick, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913080
- Sponsor's protocol ID
- 2013P000973
- Status last verified
- Jan 2017
- First submitted
- 30 Jul 2013
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
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 7352462Harris, 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 6431998Sherrer 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 3707627Callahan 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 3606681Yelin 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 7436187Meenan 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 100122Pincus 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 8250453Lorig 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 2912463Ware 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 15476213Prevoo 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01913080
- Acronym / sponsor ID
- 2013P000973
- Conditions
- Rheumatoid Arthritis
- Keywords
- health management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Sep 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 31 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Log | Active comparator | Other: Health LogPatients 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. |
| Control Pill Box | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- billing diagnosis of rheumatoid arthritis (714.0) or seronegative inflammatory arthritis and a member of the BRASS study at Brigham and Women's Hospital
Key exclusion criteria (1 listed)
- less than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health LogThe 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. | Other | Health Log |
Primary outcome
Change in Self-Efficacy
Time frame: baseline and 12 months
assessed using the Arthritis Self-Efficacy Scale
2 secondary outcomes
Change in satisfaction with the doctor's visit
Time frame: baseline and 12 months
Change in the statement "How satisfied are you that your concerns were addressed during your clinic visit today"
Time frame: baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Background: PubMed 7352462Linos 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.
- BackgroundHarris, E.D., Rheumatoid arthritis. 1997, Philadelphia: Saunders. xxiii, 433.
- Background: PubMed 6431998Pincus 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.
- Background: PubMed 3707627Sherrer 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.
- Background: PubMed 3606681Callahan 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.
- Background: PubMed 7436187Yelin 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.
- Background: PubMed 100122Meenan 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.
- Background: PubMed 8250453Pincus 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.
- Background: PubMed 2912463Lorig 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.
- BackgroundWare 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.
- Background: PubMed 15476213Wolfe 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.
- Background: PubMed 7818570Prevoo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy A Shadick, MD, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Log in people with Rheumatoid Arthritis, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-Efficacy (time frame: baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01913080, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.