Musculoskeletal DiseasesNCT01698762
IADAPT-Third Phase
An observational study of Musculoskeletal Diseases, run by M.D. Anderson Cancer Center at 3 sites in United States.
Trial summary
The goal of this research study is to compare a booklet and a DVD for patients with knee osteoarthritis, osteoporosis, or rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- Multimedia Patient Decision Aids (MM-PtDAs), Comparative Effectiveness Research Summary Guide (CERSG) and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 676 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Mar 2013to 21 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Harris County Hospital District (HCHD) and Kelsey-Seybold patients in rheumatology, internal medicine and family practice clinics.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Kelsey-Seybold Clinic
Houston, Texas, 77025
Harris County Hospital District (HCHD)
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this research study is to compare a booklet and a DVD for patients with knee osteoarthritis, osteoporosis, or rheumatoid arthritis.
Read the 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.
- Conditions
- Musculoskeletal Diseases
- Being tested
- Multimedia Patient Decision Aids (MM-PtDAs), Comparative Effectiveness Research Summary Guide (CERSG), Questionnaires
- Keywords
- 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
- Medical subject headings
- Musculoskeletal Diseases, Osteoarthritis, Arthritis, Rheumatoid, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimedia Patient Decision Aids (MM-PtDAs)Other
Also called DVD
Patient group will watch a DVD of information about their disease type.
Comparative Effectiveness Research Summary Guide (CERSG)Other
Also called Booklet, Reading material
Patient group to read a booklet about their disease type.
QuestionnairesBehavioural
Also called Surveys
Questionnaires completed at baseline, 3, and at 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Multimedia Patient Decision Aids (MM-PtDAs); Other: Comparative Effectiveness Research Summary Guide (CERSG); Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Knowledge and Therapeutic Options
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study start5 Mar 2013
- Primary completion21 Apr 2021
- Study completion21 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DiseasesStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 676 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Angeles M. Lopez-Olivo, MD, PHD, MS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698762
- Sponsor's protocol ID
- 2012-0172
- Other IDs
- 1R18HS019354-02, NCI-2016-00638
- Status last verified
- May 2021
- First submitted
- 1 Oct 2012
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Publications
Lopez-Olivo MA, des Bordes JKA, Jibaja-Weiss M, Volk RJ, Suarez-Almazor ME. Preferred Strategies for Delivering Health Information to Patients With Musculoskeletal Disorders: A Qualitative Study. J Clin Rheumatol. 2022 Jan 1;28(1):e102-e109. doi: 10.1097/RHU.0000000000001627.
PubMed 33298811Lopez-Olivo MA, Ingleshwar A, Volk RJ, Jibaja-Weiss M, Barbo A, Saag K, Leong A, Suarez-Almazor ME. Development and Pilot Testing of Multimedia Patient Education Tools for Patients With Knee Osteoarthritis, Osteoporosis, and Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2018 Feb;70(2):213-220. doi: 10.1002/acr.23271. Epub 2017 Dec 29.
PubMed 28464546Lopez-Olivo MA, Lin H, Rizvi T, Barbo Barthel A, Ingleshwar A, des Bordes JKA, Jibaja-Weiss M, Volk RJ, Suarez-Almazor ME. Randomized Controlled Trial of Patient Education Tools for Patients With Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2021 Oct;73(10):1470-1478. doi: 10.1002/acr.24362. Epub 2021 Aug 31.
PubMed 32583971Lopez-Olivo MA, des Bordes JK, Lin H, Volk RJ, Rizvi T, Suarez-Almazor ME. A Randomized Controlled Trial Comparing Two Self-Administered Educational Strategies for Patients With Knee Osteoarthritis. ACR Open Rheumatol. 2021 Mar;3(3):185-195. doi: 10.1002/acr2.11222. Epub 2021 Feb 16.
PubMed 33590950Lopez-Olivo MA, des Bordes JKA, Lin H, Rizvi T, Volk RJ, Suarez-Almazor ME. Comparison of multimedia and printed patient education tools for patients with osteoporosis: a 6-month randomized controlled trial. Osteoporos Int. 2020 May;31(5):857-866. doi: 10.1007/s00198-019-05210-4. Epub 2019 Dec 16.
PubMed 31844906
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IADAPT-Third Phase
- ClinicalTrials.gov ID
- NCT01698762
- Acronym / sponsor ID
- 2012-0172
- Conditions
- Musculoskeletal Diseases
- Keywords
- Musculoskeletal Diseases, Osteoarthritis, OA, Rheumatoid Arthritis, RA, Osteoporosis, OP, Multimedia Patient Decision Aids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 676 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 5 Mar 2013 (actual)
- Primary completion
- 21 Apr 2021 (actual)
- Study completion
- 21 Apr 2021 (actual)
- First posted
- 3 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research study is to compare a booklet and a DVD for patients with knee osteoarthritis, osteoporosis, or rheumatoid arthritis.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Osteoarthritis (OA) | – | Other: Multimedia Patient Decision Aids (MM-PtDAs), Other: Comparative Effectiveness Research Summary Guide (CERSG), Behavioral: QuestionnairesOne 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. |
| Osteoporosis (OP) | – | Other: Multimedia Patient Decision Aids (MM-PtDAs), Other: Comparative Effectiveness Research Summary Guide (CERSG), Behavioral: QuestionnairesOne 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. |
| Rheumatoid Arthritis (RA) | – | Other: Multimedia Patient Decision Aids (MM-PtDAs), Other: Comparative Effectiveness Research Summary Guide (CERSG), Behavioral: QuestionnairesOne 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Harris County Hospital District (HCHD) and Kelsey-Seybold patients in rheumatology, internal medicine and family practice clinics.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimedia Patient Decision Aids (MM-PtDAs)Also: DVDPatient group will watch a DVD of information about their disease type. | Other | Osteoarthritis (OA), Osteoporosis (OP), Rheumatoid Arthritis (RA) |
| Comparative Effectiveness Research Summary Guide (CERSG)Also: Booklet, Reading materialPatient group to read a booklet about their disease type. | Other | Osteoarthritis (OA), Osteoporosis (OP), Rheumatoid Arthritis (RA) |
| QuestionnairesAlso: SurveysQuestionnaires completed at baseline, 3, and at 6 months. | Behavioural | Osteoarthritis (OA), Osteoporosis (OP), Rheumatoid Arthritis (RA) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Background: PubMed 33298811Lopez-Olivo MA, des Bordes JKA, Jibaja-Weiss M, Volk RJ, Suarez-Almazor ME. Preferred Strategies for Delivering Health Information to Patients With Musculoskeletal Disorders: A Qualitative Study. J Clin Rheumatol. 2022 Jan 1;28(1):e102-e109. doi: 10.1097/RHU.0000000000001627.
- Background: PubMed 28464546Lopez-Olivo MA, Ingleshwar A, Volk RJ, Jibaja-Weiss M, Barbo A, Saag K, Leong A, Suarez-Almazor ME. Development and Pilot Testing of Multimedia Patient Education Tools for Patients With Knee Osteoarthritis, Osteoporosis, and Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2018 Feb;70(2):213-220. doi: 10.1002/acr.23271. Epub 2017 Dec 29.
- Background: PubMed 32583971Lopez-Olivo MA, Lin H, Rizvi T, Barbo Barthel A, Ingleshwar A, des Bordes JKA, Jibaja-Weiss M, Volk RJ, Suarez-Almazor ME. Randomized Controlled Trial of Patient Education Tools for Patients With Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2021 Oct;73(10):1470-1478. doi: 10.1002/acr.24362. Epub 2021 Aug 31.
- Background: PubMed 33590950Lopez-Olivo MA, des Bordes JK, Lin H, Volk RJ, Rizvi T, Suarez-Almazor ME. A Randomized Controlled Trial Comparing Two Self-Administered Educational Strategies for Patients With Knee Osteoarthritis. ACR Open Rheumatol. 2021 Mar;3(3):185-195. doi: 10.1002/acr2.11222. Epub 2021 Feb 16.
- Background: PubMed 31844906Lopez-Olivo MA, des Bordes JKA, Lin H, Rizvi T, Volk RJ, Suarez-Almazor ME. Comparison of multimedia and printed patient education tools for patients with osteoporosis: a 6-month randomized controlled trial. Osteoporos Int. 2020 May;31(5):857-866. doi: 10.1007/s00198-019-05210-4. Epub 2019 Dec 16.
- University of Texas MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angeles M. Lopez-Olivo, MD, PHD, MS principal investigator
M.D. Anderson Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Diseases, run by M.D. Anderson Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Knowledge and Therapeutic Options (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01698762, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.