NCT01698762

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
676

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

March 5, 2013

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2021

Completed
Last Updated

May 26, 2021

Status Verified

May 1, 2021

Enrollment Period

8.1 years

First QC Date

October 1, 2012

Last Update Submit

May 24, 2021

Conditions

Keywords

Musculoskeletal DiseasesOsteoarthritisOARheumatoid ArthritisRAOsteoporosisOPMultimedia Patient Decision AidsMM-PtDAsDVDComparative Effectiveness Research Summary GuideCERSGBookletQuestionnairesSurveys

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Study Arms (3)

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)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.

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.

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

Interventions

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

Also known as: DVD
Osteoarthritis (OA)Osteoporosis (OP)Rheumatoid Arthritis (RA)

Patient group to read a booklet about their disease type.

Also known as: Booklet, Reading material
Osteoarthritis (OA)Osteoporosis (OP)Rheumatoid Arthritis (RA)
QuestionnairesBEHAVIORAL

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

Also known as: Surveys
Osteoarthritis (OA)Osteoporosis (OP)Rheumatoid Arthritis (RA)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kelsey-Seybold Clinic

Houston, Texas, 77025, United States

Location

Harris County Hospital District (HCHD)

Houston, Texas, 77030, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (5)

  • 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.

    PMID: 33298811BACKGROUND
  • Lopez-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.

    PMID: 28464546BACKGROUND
  • Lopez-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.

    PMID: 32583971BACKGROUND
  • Lopez-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.

    PMID: 33590950BACKGROUND
  • Lopez-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.

    PMID: 31844906BACKGROUND

Related Links

MeSH Terms

Conditions

Musculoskeletal DiseasesOsteoarthritisArthritis, RheumatoidOsteoporosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBone Diseases, MetabolicBone DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

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

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2012

First Posted

October 3, 2012

Study Start

March 5, 2013

Primary Completion

April 21, 2021

Study Completion

April 21, 2021

Last Updated

May 26, 2021

Record last verified: 2021-05

Locations