IADAPT-Third Phase

This study is currently recruiting participants.
Verified February 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborators:
Harris County Hospital District
Kelsey-Seybold Clinics
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01698762
First received: October 1, 2012
Last updated: February 24, 2014
Last verified: February 2014

October 1, 2012
February 24, 2014
March 2013
March 2018   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01698762 on ClinicalTrials.gov Archive Site
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IADAPT-Third Phase
IADAPT-Third Phase

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

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

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

Musculoskeletal Diseases
  • 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:
    • Booklet
    • Reading material
  • Behavioral: Questionnaires
    Questionnaires completed at baseline, 3, and at 6 months.
    Other Name: Surveys
  • 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.

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

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

    Interventions:
    • Other: Multimedia Patient Decision Aids (MM-PtDAs)
    • Other: Comparative Effectiveness Research Summary Guide (CERSG)
    • Behavioral: Questionnaires
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
828
Not Provided
March 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Knee Osteoarthritis (OA): (a) age 50 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 50 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.
Both
18 Years and older
Yes
Contact: Angeles M. Lopez-Olivo, MD, PHD, MS IADAPTstudy@mdanderson.org
Contact: Vincent Richards, BA 713-745-0036 IADAPTstudy@mdanderson.org
United States
 
NCT01698762
2012-0172, 1R18HS019354-02
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
  • Agency for Healthcare Research and Quality (AHRQ)
  • Harris County Hospital District
  • Kelsey-Seybold Clinics
Principal Investigator: Angeles M. Lopez-Olivo, MD, PHD, MS UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP