IADAPT-Third Phase

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 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: April 22, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Musculoskeletal Diseases
Other: Multimedia Patient Decision Aids (MM-PtDAs)
Other: Comparative Effectiveness Research Summary Guide (CERSG)
Behavioral: Questionnaires

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: IADAPT-Third Phase

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 828
Study Start Date: March 2013
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 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
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 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
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 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698762

Contacts
Contact: Angeles M. Lopez-Olivo, MD, PHD, MS IADAPTstudy@mdanderson.org
Contact: Vincent Richards, BA 713-745-0036 IADAPTstudy@mdanderson.org

Locations
United States, Texas
Harris County Hospital District (HCHD) Recruiting
Houston, Texas, United States, 77030
Contact       IADAPTstudy@mdanderson.org   
Kelsey-Seybold Clinic Recruiting
Houston, Texas, United States, 77025
Contact       IADAPTstudy@mdanderson.org   
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Vincent Richards       IADAPTstudy@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
Harris County Hospital District
Kelsey-Seybold Clinics
Investigators
Principal Investigator: Angeles M. Lopez-Olivo, MD, PHD, MS UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01698762     History of Changes
Other Study ID Numbers: 2012-0172, 1R18HS019354-02
Study First Received: October 1, 2012
Last Updated: April 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Musculoskeletal Diseases
Osteoarthritis
OA
Rheumatoid Arthritis
RA
Osteoporosis
OP
Multimedia Patient Decision Aids
MM-PtDAs
DVD
Comparative Effectiveness Research Summary Guide
CERSG
Booklet
Questionnaires
Surveys

Additional relevant MeSH terms:
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 28, 2014