Overview

This trial is active, not recruiting.

Condition musculoskeletal diseases
Treatments multimedia patient decision aids (mm-ptdas), comparative effectiveness research summary guide (cersg), questionnaires
Sponsor M.D. Anderson Cancer Center
Collaborator Agency for Healthcare Research and Quality (AHRQ)
Start date March 2013
End date March 2018
Trial size 828 participants
Trial identifier NCT01698762, 1R18HS019354-02, 2012-0172

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
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.
multimedia patient decision aids (mm-ptdas) DVD
Patient group will watch a DVD of information about their disease type.
comparative effectiveness research summary guide (cersg) Booklet
Patient group to read a booklet about their disease type.
questionnaires Surveys
Questionnaires completed at baseline, 3, and at 6 months.
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.
multimedia patient decision aids (mm-ptdas) DVD
Patient group will watch a DVD of information about their disease type.
comparative effectiveness research summary guide (cersg) Booklet
Patient group to read a booklet about their disease type.
questionnaires Surveys
Questionnaires completed at baseline, 3, and at 6 months.
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.
multimedia patient decision aids (mm-ptdas) DVD
Patient group will watch a DVD of information about their disease type.
comparative effectiveness research summary guide (cersg) Booklet
Patient group to read a booklet about their disease type.
questionnaires Surveys
Questionnaires completed at baseline, 3, and at 6 months.

Primary Outcomes

Measure
Disease Knowledge and Therapeutic Options
time frame: 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title IADAPT-Third Phase
Principal investigator Angeles M. Lopez-Olivo, MD, PHD, MS
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.