IADAPT-Third Phase

Completed

• Conditions: Musculoskeletal Diseases
• Interventions: Other: Multimedia Patient Decision Aids (MM-PtDAs); Other: Comparative Effectiveness Research Summary Guide (CERSG); Behavioral: Questionnaires

• Registration Number: NCT01698762
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2012-10-01
• Study First Submitted QC: 2012-10-01
• Study First Posted: 2012-10-03
• Study Start: 2013-03-05
• Primary Completion: 2021-04-21
• Study Completion: 2021-04-21
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-24
• Last Update Posted: 2021-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 676

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Osteoarthritis (OA)	Comparative Effectiveness Research Summary Guide (CERSG)	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.
Osteoporosis (OP)	Multimedia Patient Decision Aids (MM-PtDAs)	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.
Osteoarthritis (OA)	Multimedia Patient Decision Aids (MM-PtDAs)	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.
Osteoporosis (OP)	Comparative Effectiveness Research Summary Guide (CERSG)	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.
Rheumatoid Arthritis (RA)	Comparative Effectiveness Research Summary Guide (CERSG)	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.
Osteoarthritis (OA)	Questionnaires	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.
Rheumatoid Arthritis (RA)	Questionnaires	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.
Osteoporosis (OP)	Questionnaires	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.
Rheumatoid Arthritis (RA)	Multimedia Patient Decision Aids (MM-PtDAs)	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.

Primary Outcome Measures

Name	Time	Method
Disease Knowledge and Therapeutic Options	3 months	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.

Trial Locations

Locations (3)

Kelsey-Seybold Clinic; 🇺🇸 Houston, Texas, United States

Harris County Hospital District (HCHD); 🇺🇸 Houston, Texas, United States

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States