IADAPT-Third Phase

Musculoskeletal Diseases Clinical Trial

Official title:

IADAPT-Third Phase

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01698762
• Other study ID #: 2012-0172
• Secondary ID: 1R18HS019354-02N
• Status: Completed
• Start date: March 5, 2013
• Est. completion date: April 21, 2021

Study information

• Verified date: May 2021
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this research study is to compare a booklet and a DVD for patients with knee osteoarthritis, osteoporosis, or rheumatoid arthritis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 676
• Est. completion date: April 21, 2021
• Est. primary completion date: April 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Knee Osteoarthritis (OA): (a) age 45 and over (b) prior diagnosis of knee OA (unilateral or bilateral) by a physician.

2. 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

3. Osteoporosis (OP): (a) female gender, (b) age 45 and over, (c) and at least 3 years post-menopausal

4. Adequate cognitive status as determined by the research assistant (see description in "Recruitment Eligibility")

5. Ability to communicate in English or Spanish language without a translator

6. Have access to a telephone

Exclusion Criteria:

1. Hospitalized

2. Patients with RA or knee OA who also have any other connective tissue disease or spondyloarthropathy.

3. Patients with diagnosis of RA and disease duration (>10 years)

4. Patients who do not sign the informed consent

Related Conditions & MeSH terms

• Musculoskeletal Diseases

Intervention

Other:
• Multimedia Patient Decision Aids (MM-PtDAs)
Patient group will watch a DVD of information about their disease type.
• Comparative Effectiveness Research Summary Guide (CERSG)
Patient group to read a booklet about their disease type.

Behavioral:
• Questionnaires
Questionnaires completed at baseline, 3, and at 6 months.

Locations

Country	Name	City	State
United States	Harris County Hospital District (HCHD)	Houston	Texas
United States	Kelsey-Seybold Clinic	Houston	Texas
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & Publications (5)

Lopez-Olivo MA, des Bordes JK, Lin H, Volk RJ, Rizvi T, Suarez-Almazor ME. A Randomized Controlled Trial Comparing Two Self-Administered Educational Strategies for Patients With Knee Osteoarthritis. ACR Open Rheumatol. 2021 Mar;3(3):185-195. doi: 10.1002/acr2.11222. Epub 2021 Feb 16. — View Citation

Lopez-Olivo MA, des Bordes JKA, Jibaja-Weiss M, Volk RJ, Suarez-Almazor ME. Preferred Strategies for Delivering Health Information to Patients With Musculoskeletal Disorders: A Qualitative Study. J Clin Rheumatol. 2020 Dec 8. doi: 10.1097/RHU.0000000000001627. [Epub ahead of print] — View Citation

Lopez-Olivo MA, des Bordes JKA, Lin H, Rizvi T, Volk RJ, Suarez-Almazor ME. Comparison of multimedia and printed patient education tools for patients with osteoporosis: a 6-month randomized controlled trial. Osteoporos Int. 2020 May;31(5):857-866. doi: 10.1007/s00198-019-05210-4. Epub 2019 Dec 16. — View Citation

Lopez-Olivo MA, Ingleshwar A, Volk RJ, Jibaja-Weiss M, Barbo A, Saag K, Leong A, Suarez-Almazor ME. Development and Pilot Testing of Multimedia Patient Education Tools for Patients With Knee Osteoarthritis, Osteoporosis, and Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2018 Feb;70(2):213-220. doi: 10.1002/acr.23271. Epub 2017 Dec 29. — View Citation

Lopez-Olivo MA, Lin H, Rizvi T, Barbo A, Ingleshwar A, des Bordes JKA, Jibaja-Weiss M, Volk RJ, Suarez-Almazor ME. Randomized Controlled Trial of Patient Education Tools for Patients with Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2020 Jun 25. doi: 10.1002/acr.24362. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Knowledge and Therapeutic Options	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.	3 months

External Links

•   University of Texas MD Anderson Cancer Center