IADAPT-Third Phase

May 24, 2021 updated by: M.D. Anderson Cancer Center
The goal of this research study is to compare a booklet and a DVD for patients with knee osteoarthritis, osteoporosis, or rheumatoid arthritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

676

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
      • Houston, Texas, United States, 77025
        • Kelsey-Seybold Clinic
      • Houston, Texas, United States, 77030
        • Harris County Hospital District (HCHD)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Harris County Hospital District (HCHD) and Kelsey-Seybold patients in rheumatology, internal medicine and family practice clinics.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • DVD
Other: Comparative Effectiveness Research Summary Guide (CERSG)
Patient group to read a booklet about their disease type.
Other Names:
  • Booklet
  • Reading material
Behavioral: Questionnaires
Questionnaires completed at baseline, 3, and at 6 months.
Other Names:
  • 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 Names:
  • DVD
Other: Comparative Effectiveness Research Summary Guide (CERSG)
Patient group to read a booklet about their disease type.
Other Names:
  • Booklet
  • Reading material
Behavioral: Questionnaires
Questionnaires completed at baseline, 3, and at 6 months.
Other Names:
  • 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 Names:
  • DVD
Other: Comparative Effectiveness Research Summary Guide (CERSG)
Patient group to read a booklet about their disease type.
Other Names:
  • Booklet
  • Reading material
Behavioral: Questionnaires
Questionnaires completed at baseline, 3, and at 6 months.
Other Names:
  • Surveys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Knowledge and Therapeutic Options
Time Frame: 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Angeles M. Lopez-Olivo, MD, PHD, MS, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2013

Primary Completion (Actual)

April 21, 2021

Study Completion (Actual)

April 21, 2021

Study Registration Dates

First Submitted

October 1, 2012

First Submitted That Met QC Criteria

October 1, 2012

First Posted (Estimate)

October 3, 2012

Study Record Updates

Last Update Posted (Actual)

May 26, 2021

Last Update Submitted That Met QC Criteria

May 24, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-0172
  • 1R18HS019354-02 (U.S. AHRQ Grant/Contract)
  • NCI-2016-00638 (Registry Identifier: NCI-CTRP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Musculoskeletal Diseases

Clinical Trials on Multimedia Patient Decision Aids (MM-PtDAs)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe