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OpenTrials
Completed

NCT Number: NCT01698762

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Knee Osteoarthritis (OA): (a) age 45 and over (b) prior diagnosis of knee OA (unilateral or bilateral) by a physician.
  • 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
  • Osteoporosis (OP): (a) female gender, (b) age 45 and over, (c) and at least 3 years post-menopausal
  • Adequate cognitive status as determined by the research assistant (see description in "Recruitment Eligibility")
  • Ability to communicate in English or Spanish language without a translator
  • Have access to a telephone

Exclusion criteria

  • Hospitalized
  • Patients with RA or knee OA who also have any other connective tissue disease or spondyloarthropathy.
  • Patients with diagnosis of RA and disease duration (>10 years)
  • Patients who do not sign the informed consent

Treatment and study plan

Multimedia Patient Decision Aids (MM-PtDAs)

Other

Patient group will watch a DVD of information about their disease type.

Other names: DVD

Comparative Effectiveness Research Summary Guide (CERSG)

Other

Patient group to read a booklet about their disease type.

Other names: Booklet, Reading material

Questionnaires

Behavioral

Questionnaires completed at baseline, 3, and at 6 months.

Other names: Surveys

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Oct 3, 2012
Registry last updated
May 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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