IADAPT-Third Phase
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Purpose
The goal of this research study is to compare a booklet and a DVD for patients with knee osteoarthritis, osteoporosis, or rheumatoid arthritis.
Objectives:
Our primary objective is to evaluate the efficacy in improving treatment knowledge of the multimedia patient decision aids (MM-PtDAs), compared to current Comparative Effectiveness Research Summary Guide (CERSG) products, in randomized clinical trials (RCT), to include economically disadvantaged and ethnic minority patients with knee OA, RA, and OP.
| Condition | Intervention |
|---|---|
|
Musculoskeletal Diseases |
Other: Multimedia Patient Decision Aids (MM-PtDAs) Other: Comparative Effectiveness Research Summary Guide (CERSG) Behavioral: Questionnaires |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | IADAPT-Third Phase |
- Disease Knowledge and Therapeutic Options [ Time Frame: 3 months ] [ Designated as safety issue: No ]Primary analyses performed using repeated measures ANOVA, with group allocation - multimedia patient decision aids (MM-PtDA) vs. Comparative Effectiveness Research Summary Guide (CERSG) as the factor of interest and knowledge as the central outcome measure.
| Estimated Enrollment: | 828 |
| Study Start Date: | March 2013 |
| Estimated Primary Completion Date: | March 2018 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Osteoarthritis (OA)
One OA group will watch a DVD - Multimedia Patient Decision Aids (MM-PtDAs) of information about their disease type. One OA group will read a booklet - Comparative Effectiveness Research Summary Guide (CERSG) about their disease type. Questionnaires completed at baseline, 3, and at 6 months. |
Other: Multimedia Patient Decision Aids (MM-PtDAs)
Patient group will watch a DVD of information about their disease type.
Other Name: DVD
Other: Comparative Effectiveness Research Summary Guide (CERSG)
Patient group to read a booklet about their disease type.
Other Names:
Behavioral: Questionnaires
Questionnaires completed at baseline, 3, and at 6 months.
Other Name: Surveys
|
|
Osteoporosis (OP)
One OP group will watch a DVD - Multimedia Patient Decision Aids (MM-PtDAs) of information about their disease type. One OP group will read a booklet - Comparative Effectiveness Research Summary Guide (CERSG) about their disease type. Questionnaires completed at baseline, 3, and at 6 months. |
Other: Multimedia Patient Decision Aids (MM-PtDAs)
Patient group will watch a DVD of information about their disease type.
Other Name: DVD
Other: Comparative Effectiveness Research Summary Guide (CERSG)
Patient group to read a booklet about their disease type.
Other Names:
Behavioral: Questionnaires
Questionnaires completed at baseline, 3, and at 6 months.
Other Name: Surveys
|
|
Rheumatoid Arthritis (RA)
One RA group will watch a DVD - Multimedia Patient Decision Aids (MM-PtDAs) of information about their disease type. One RA group will read a booklet - Comparative Effectiveness Research Summary Guide (CERSG) about their disease type. Questionnaires completed at baseline, 3, and at 6 months. |
Other: Multimedia Patient Decision Aids (MM-PtDAs)
Patient group will watch a DVD of information about their disease type.
Other Name: DVD
Other: Comparative Effectiveness Research Summary Guide (CERSG)
Patient group to read a booklet about their disease type.
Other Names:
Behavioral: Questionnaires
Questionnaires completed at baseline, 3, and at 6 months.
Other Name: Surveys
|
Detailed Description:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups:
- Group 1 will watch a DVD and receive a booklet of information about their disease type (knee osteoarthritis, osteoporosis, or rheumatoid arthritis).
- Group 2 will read a booklet about their disease type.
All the materials including the DVD, booklet, and questionnaires will be in English and Spanish. You may choose which language you prefer to use while watching and/or reading the materials.
You will be asked to complete questionnaires before and after watching the DVD or reading the booklet. We will ask you about how the material made you think and feel and how easy or hard the material was to understand.
You will also fill out short questionnaires that include questions about your demographic information, your health, your thoughts about bone/joint disease, how you might choose treatments for bone/joint disease, and how you make treatment decisions. These questionnaires will take up to 45 minutes to complete in the clinic.
This first visit will take about 60-90 minutes total to complete. If you are unable to complete this first visit today you will need to complete it within the next two weeks.
You will be asked to fill out these questionnaires again 3 months and 6 months later, by mail. The study staff will mail you the questionnaires, along with a postage-paid return envelope that you can use to send the questionnaires back. If you prefer you can also complete the questionnaires over the phone or the research staff can meet you at the clinic or your home to complete the questionnaires at 3 and 6 months.
Your participation on this study will be over after you have mailed back the 6-month questionnaires.
This is an investigational study.
Up to 828 participants will take part in this multicenter study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Harris County Hospital District (HCHD) and Kelsey-Seybold patients in rheumatology, internal medicine and family practice clinics.
Inclusion Criteria:
- Knee Osteoarthritis (OA): (a) age 50 and over (b) prior diagnosis of knee OA (unilateral or bilateral) by a physician.
- Rheumatoid Arthritis (RA): (a) age 18 and over, (b) compliance with American College of Rheumatology criteria for the diagnosis of RA, (c) and disease duration < or = 10 years
- Osteoporosis (OP): (a) female gender, (b) age 50 and over, (c) and at least 3 years post-menopausal
- Adequate cognitive status as determined by the research assistant (see description in "Recruitment Eligibility")
- Ability to communicate in English or Spanish language without a translator
- Have access to a telephone
Exclusion Criteria:
- Hospitalized
- Patients with RA or knee OA who also have any other connective tissue disease or spondyloarthropathy.
- Patients with diagnosis of RA and disease duration (>10 years)
- Patients who do not sign the informed consent
Contacts and Locations| Contact: Angeles M. Lopez-Olivo, MD, PHD, MS | IADAPTstudy@mdanderson.org | |
| Contact: Vincent Richards, BA | 713-745-0036 | IADAPTstudy@mdanderson.org |
| United States, Texas | |
| Harris County Hospital District (HCHD) | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact IADAPTstudy@mdanderson.org | |
| Kelsey-Seybold Clinic | Recruiting |
| Houston, Texas, United States, 77025 | |
| Contact IADAPTstudy@mdanderson.org | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Vincent Richards IADAPTstudy@mdanderson.org | |
| Principal Investigator: | Angeles M. Lopez-Olivo, MD, PHD, MS | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01698762 History of Changes |
| Other Study ID Numbers: | 2012-0172 |
| Study First Received: | October 1, 2012 |
| Last Updated: | March 28, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Musculoskeletal Diseases Osteoarthritis OA Rheumatoid Arthritis RA Osteoporosis OP Multimedia Patient Decision Aids |
MM-PtDAs DVD Comparative Effectiveness Research Summary Guide CERSG Booklet Questionnaires Surveys |
Additional relevant MeSH terms:
|
Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013