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IADAPT-Third Phase


N/A
18 Years
N/A
Open (Enrolling)
Both
Musculoskeletal Diseases

Thank you

Trial Information

IADAPT-Third Phase


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Disease Knowledge and Therapeutic Options

Outcome Description:

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.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Angeles M. Lopez-Olivo, MD, PHD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2012-0172

NCT ID:

NCT01698762

Start Date:

March 2013

Completion Date:

Related Keywords:

  • Musculoskeletal Diseases
  • 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
  • Musculoskeletal Diseases

Name

Location

UT MD Anderson Cancer Center Houston, Texas  77030
Harris County Hospital District (HCHD) Houston, Texas  77030
Kelsey-Seybold Clinic Houston, Texas  77025