Rheumatoid ArthritisPhase 2NCT00023205
Impact of Literacy Level on Patient Education and Health Among People With Arthritis
A Phase 2 study testing 11th grade reading level arthritis materials and Interactive in-person arthritis education in people with Rheumatoid Arthritis and Psoriatic Arthritis, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
People with poor literacy may have worse health and less knowledge about how to manage their disease than patients at high reading levels. Patients with arthritis usually receive information on how to manage their disease that is written at an 11th grade reading level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Psoriatic Arthritis, Polyarthritis
- What is being tested?
- 11th grade reading level arthritis materials and Interactive in-person arthritis education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Dec 2006
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Native English speaker
- Patient at the Rheumatology Clinic at Brigham and Women's Hospital, Boston, Massachusetts
- Diagnosis of rheumatoid arthritis, psoriatic arthritis, or seronegative polyarthritis
Who cannot join
None listed.
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: Literacy in Arthritis Management: A Randomized Controlled Clinical Trial of a Novel Education Intervention
People with poor literacy may have worse health and less knowledge about how to manage their disease than patients at high reading levels. Patients with arthritis usually receive information on how to manage their disease that is written at an 11th grade reading level. The purpose of this study is to compare the health outcomes of patients with arthritis given either standard 11th grade level materials or interactive, in-person arthritis education along with materials written at a lower reading level.
Read the detailed description
Patients with poor literacy report worse health and know less about managing their disease than patients with better literacy. This study will compare the disease outcomes of arthritis patients at three different reading levels who receive either standard arthritis materials written at an 11th grade reading level or an in-person, interactive, text-free session along with lower reading level materials. The study will determine the most effective methods of educating patients with poor literacy about their disease.
Patients with systemic inflammatory rheumatic conditions (rheumatoid arthritis, psoriatic arthritis, and seronegative polyarthritis) will be assessed and placed into one of three reading levels: 8th grade or lower; 9th to 11th grade; or 12th grade or higher. Patients from each reading level will be randomly assigned to one of two intervention groups. Group 1 will receive disease-specific material from the Arthritis Foundation written at an 11th grade reading level. Group 2 will receive plain language materials, an arthritis glossary, and a one-hour, in-person session with a study educator using interactive, text-free methods. The study educator will help the patient with reading-related problems either by study visit or by telephone for 6 months postsession.
All patients will receive a medication calendar. Patients will be followed for one year after the intervention and will be assessed for changes in health status, disease activity, communication with the physician, self-management of their arthritis, understanding of and adherence to prescribed treatment, and satisfaction with their intervention.
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Polyarthritis
- Being tested
- 11th grade reading level arthritis materials, Interactive in-person arthritis education
- Keywords
- Arthritis, Health literacy, Patient education, Self-efficacy
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11th grade reading level arthritis materialsBehavioural
Interactive in-person arthritis educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Individualized education | Experimental | Individualized education with materials written in plain language. Follow-up sessions/ phone contact as requested by the subject. Receives: Behavioral: Interactive in-person arthritis education |
| Standard care | Active comparator | 1 session of education with provision of standard Arthritis Foundation materials. Receives: Behavioral: 11th grade reading level arthritis materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to treatment
self report of medication use on standard form
Measured: 6 months, 12 months
Self efficacy
self report on self efficacy form
Measured: 6 months and 12 months
Satisfaction with medical care
self report of satisfaction
Measured: 6 months and 12 months
Secondary outcomes (5)
Heath Status
Health Assessment questionaire
Measured: 6 months and 12 months
Mental Health
SF-36 (5 items)
Measured: 6 months and 12 months
Understanding of medication
open ended questionnaire of medication purpose
Measured: 6 months and 12 months
Perceived usefulness of materials
Interview
Measured: 6months and 12 months
Appointment keeping
Clinical record
Measured: 6 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 Aug 2001 (estimated)
- Study startNov 2002
- Primary completionAug 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Matthew H. Liang, MD, Brigham and Women's Hospital
- Investigators
- Matthew H. Liang, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00023205
- Sponsor's protocol ID
- P60 AR47782 NIAMS-068
- Other IDs
- P60AR047782
- Status last verified
- Dec 2013
- First submitted
- 29 Aug 2001
- Last updated
- 24 Dec 2013
- Results posted
- No
Publications
Weiss BD, Hart G, McGee DL, D'Estelle S. Health status of illiterate adults: relation between literacy and health status among persons with low literacy skills. J Am Board Fam Pract. 1992 May-Jun;5(3):257-64.
PubMed 1580173Kitsch I, A. Jungeblut, L. Jenkins, and A. Kolstad. Adult Literacy in America: A First Look at the Results of the National Adult Literacy Survey. Washington, DC: National Center for Education Statistics, US Department of Education; 1993.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Literacy in Arthritis Management: A Randomized Controlled Clinical Trial of a Novel Education Intervention
- ClinicalTrials.gov ID
- NCT00023205
- Acronym / sponsor ID
- P60 AR47782 NIAMS-068
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Polyarthritis
- Keywords
- Arthritis, Health literacy, Patient education, Self-efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Nov 2002
- Primary completion
- Aug 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 31 Aug 2001 (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.
People with poor literacy may have worse health and less knowledge about how to manage their disease than patients at high reading levels. Patients with arthritis usually receive information on how to manage their disease that is written at an 11th grade reading level. The purpose of this study is to compare the health outcomes of patients with arthritis given either standard 11th grade level materials or interactive, in-person arthritis education along with materials written at a lower reading level.
Detailed description
Patients with poor literacy report worse health and know less about managing their disease than patients with better literacy. This study will compare the disease outcomes of arthritis patients at three different reading levels who receive either standard arthritis materials written at an 11th grade reading level or an in-person, interactive, text-free session along with lower reading level materials. The study will determine the most effective methods of educating patients with poor literacy about their disease.
Patients with systemic inflammatory rheumatic conditions (rheumatoid arthritis, psoriatic arthritis, and seronegative polyarthritis) will be assessed and placed into one of three reading levels: 8th grade or lower; 9th to 11th grade; or 12th grade or higher. Patients from each reading level will be randomly assigned to one of two intervention groups. Group 1 will receive disease-specific material from the Arthritis Foundation written at an 11th grade reading level. Group 2 will receive plain language materials, an arthritis glossary, and a one-hour, in-person session with a study educator using interactive, text-free methods. The study educator will help the patient with reading-related problems either by study visit or by telephone for 6 months postsession.
All patients will receive a medication calendar. Patients will be followed for one year after the intervention and will be assessed for changes in health status, disease activity, communication with the physician, self-management of their arthritis, understanding of and adherence to prescribed treatment, and satisfaction with their intervention.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized education | Experimental | Behavioral: Interactive in-person arthritis educationIndividualized education with materials written in plain language. Follow-up sessions/ phone contact as requested by the subject. |
| Standard care | Active comparator | Behavioral: 11th grade reading level arthritis materials1 session of education with provision of standard Arthritis Foundation materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Native English speaker
- Patient at the Rheumatology Clinic at Brigham and Women's Hospital, Boston, Massachusetts
- Diagnosis of rheumatoid arthritis, psoriatic arthritis, or seronegative polyarthritis
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| 11th grade reading level arthritis materials | Behavioural | Standard care |
| Interactive in-person arthritis education | Behavioural | Individualized education |
Primary outcome
Adherence to treatment
Time frame: 6 months, 12 months
self report of medication use on standard form
Self efficacy
Time frame: 6 months and 12 months
self report on self efficacy form
Satisfaction with medical care
Time frame: 6 months and 12 months
self report of satisfaction
5 secondary outcomes
Heath Status
Time frame: 6 months and 12 months
Mental Health
Time frame: 6 months and 12 months
Understanding of medication
Time frame: 6 months and 12 months
Perceived usefulness of materials
Time frame: 6months and 12 months
Appointment keeping
Time frame: 6 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 24 Dec 2013.
- Background: PubMed 1580173Weiss BD, Hart G, McGee DL, D'Estelle S. Health status of illiterate adults: relation between literacy and health status among persons with low literacy skills. J Am Board Fam Pract. 1992 May-Jun;5(3):257-64.
- BackgroundKitsch I, A. Jungeblut, L. Jenkins, and A. Kolstad. Adult Literacy in America: A First Look at the Results of the National Adult Literacy Survey. Washington, DC: National Center for Education Statistics, US Department of Education; 1993.
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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.
Matthew H. Liang, 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 Phase 2 study testing 11th grade reading level arthritis materials and Interactive in-person arthritis education in people with Rheumatoid Arthritis and Psoriatic 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 3 inclusion and 0 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 24 Dec 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Adherence to treatment (time frame: 6 months, 12 months). The study lists 3 primary outcomes in all. 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 NCT00023205, which also lists 2 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 24 Dec 2013.