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A Direct-to-patient Intervention to Increase Rates of Osteoporosis Care (APROPOS)

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video-based Intervention
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Self-reported history of fracture

Exclusion Criteria:

  • Self-reported current prescription osteoporosis treatment

Sites / Locations

  • University of Alabama at Birmingham
  • Cedars-Sinai Medical Center
  • University of Massachusetts at Worcester
  • New York University
  • Jewish Hospital of Cincinnati
  • University of Pittsburgh
  • Group Health Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Video-based intervention

Usual care

Arm Description

Video-based intervention providing personalized feedback regarding patients' risk of subsequent fractures, customized information regarding osteoporosis care, and messaging to activate patients to become more engaged in improving osteoporosis treatment and doctor-patient communication. This novel content will use "story-telling" delivered via the Internet and DVDs. The content will be uniquely tailored to each person based on their reported barriers to care, age and race/ethnicity. The video-based intervention materials will be augmented by a personal phone call and interactive voice response messaging.

Outcomes

Primary Outcome Measures

Number of Participants That Initiate an Osteoporosis Prescription Medication
We will assess the number of participants that self-report the initiation of an osteoporosis prescription medication. It will be assessed using a self-completed survey. Osteoporosis prescription medications that will be assessed include: alendronate, calcitonin, denosumab ibandronate, raloxifene, risedronate, teriparatide, and zoledronic acid. We will not include initiation of estrogen hormone therapies as part of the primary outcome.

Secondary Outcome Measures

Number of Participants Who Reported Use of Calcium and Vitamin D
We will assess the use of calcium and vitamin D by participant. This will be assessed on a self-completed survey. Participants will be asked if they are currently taking a calcium supplement and/or vitamin D supplement.
Number of Participants Who Reported Receipt of Bone Mineral Density (BMD) Testing
Self-report of a receipt of a DXA scan (Bone Mineral Density test).
Number of Participants That Initiate an Osteoporosis Prescription Medication
We will assess the number of participants that self-report the initiation of an osteoporosis prescription medication. It will be assessed using a self-completed survey. Osteoporosis prescription medications that will be assessed include: alendronate, calcitonin, denosumab ibandronate, raloxifene, risedronate, teriparatide, and zoledronic acid. We will not include initiation of estrogen hormone therapies as part of the outcome.

Full Information

First Posted
July 11, 2013
Last Updated
May 29, 2018
Sponsor
University of Alabama at Birmingham
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Massachusetts, Worcester, Helen Hayes Hospital, Kaiser Permanente, Cedars-Sinai Medical Center, University of Pittsburgh, University of Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT01907269
Brief Title
A Direct-to-patient Intervention to Increase Rates of Osteoporosis Care
Acronym
APROPOS
Official Title
Activating Patients to Reduce OsteoPOrosiS
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Massachusetts, Worcester, Helen Hayes Hospital, Kaiser Permanente, Cedars-Sinai Medical Center, University of Pittsburgh, University of Cincinnati

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to conduct a randomized trial of a tailored intervention designed to provide personalized feedback regarding patients' risk of subsequent fractures, customized information regarding osteoporosis care, and messaging to activate patients to become more engaged in improving osteoporosis treatment and doctor-patient communication. This novel content will use "story-telling" delivered via the Internet and digital video discs (DVDs). The content will be uniquely tailored to each person based on barriers to care, age and race/ethnicity. We will conduct a controlled, cluster-randomized trial of this intervention to determine differences in post-intervention rates of osteoporosis care between two randomization arms. We hypothesize that participants randomized to the intervention arm, compared to those randomized to a control arm, will receive more osteoporosis care at 6 months post-intervention, as evidenced by higher rates of: (H1) Prescription osteoporosis therapies, (H2) Non-prescription therapy with calcium and vitamin D, and (H3) Bone mineral density (BMD) testing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
2684 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Video-based intervention
Arm Type
Experimental
Arm Description
Video-based intervention providing personalized feedback regarding patients' risk of subsequent fractures, customized information regarding osteoporosis care, and messaging to activate patients to become more engaged in improving osteoporosis treatment and doctor-patient communication. This novel content will use "story-telling" delivered via the Internet and DVDs. The content will be uniquely tailored to each person based on their reported barriers to care, age and race/ethnicity. The video-based intervention materials will be augmented by a personal phone call and interactive voice response messaging.
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Video-based Intervention
Intervention Description
Video clips delivered by DVD and Internet
Primary Outcome Measure Information:
Title
Number of Participants That Initiate an Osteoporosis Prescription Medication
Description
We will assess the number of participants that self-report the initiation of an osteoporosis prescription medication. It will be assessed using a self-completed survey. Osteoporosis prescription medications that will be assessed include: alendronate, calcitonin, denosumab ibandronate, raloxifene, risedronate, teriparatide, and zoledronic acid. We will not include initiation of estrogen hormone therapies as part of the primary outcome.
Time Frame
6 months post-intervention
Secondary Outcome Measure Information:
Title
Number of Participants Who Reported Use of Calcium and Vitamin D
Description
We will assess the use of calcium and vitamin D by participant. This will be assessed on a self-completed survey. Participants will be asked if they are currently taking a calcium supplement and/or vitamin D supplement.
Time Frame
6 and 18 months post-intervention
Title
Number of Participants Who Reported Receipt of Bone Mineral Density (BMD) Testing
Description
Self-report of a receipt of a DXA scan (Bone Mineral Density test).
Time Frame
6 and 18 months post-intervention
Title
Number of Participants That Initiate an Osteoporosis Prescription Medication
Description
We will assess the number of participants that self-report the initiation of an osteoporosis prescription medication. It will be assessed using a self-completed survey. Osteoporosis prescription medications that will be assessed include: alendronate, calcitonin, denosumab ibandronate, raloxifene, risedronate, teriparatide, and zoledronic acid. We will not include initiation of estrogen hormone therapies as part of the outcome.
Time Frame
18 months
Other Pre-specified Outcome Measures:
Title
Number of Participants Who Reported Communicating With a Health Care Provider About Osteoporosis Care
Time Frame
6 and 18 months post-intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Self-reported history of fracture Exclusion Criteria: Self-reported current prescription osteoporosis treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth G Saag, MD, MSc
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of Massachusetts at Worcester
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Jewish Hospital of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Group Health Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18787907
Citation
Yood RA, Mazor KM, Andrade SE, Emani S, Chan W, Kahler KH. Patient decision to initiate therapy for osteoporosis: the influence of knowledge and beliefs. J Gen Intern Med. 2008 Nov;23(11):1815-21. doi: 10.1007/s11606-008-0772-0. Epub 2008 Sep 12.
Results Reference
background
PubMed Identifier
3049068
Citation
Weinstein ND. The precaution adoption process. Health Psychol. 1988;7(4):355-86. doi: 10.1037//0278-6133.7.4.355.
Results Reference
background
PubMed Identifier
27453960
Citation
Danila MI, Outman RC, Rahn EJ, Mudano AS, Thomas TF, Redden DT, Allison JJ, Anderson FA, Anderson JP, Cram PM, Curtis JR, Fraenkel L, Greenspan SL, LaCroix AZ, Majumdar SR, Miller MJ, Nieves JW, Safford MM, Silverman SL, Siris ES, Solomon DH, Warriner AH, Watts NB, Yood RA, Saag KG. A multi-modal intervention for Activating Patients at Risk for Osteoporosis (APROPOS): Rationale, design, and uptake of online study intervention material. Contemp Clin Trials Commun. 2016 Dec 15;4:14-24. doi: 10.1016/j.conctc.2016.06.010.
Results Reference
result
PubMed Identifier
29377378
Citation
Danila MI, Outman RC, Rahn EJ, Mudano AS, Redden DT, Li P, Allison JJ, Anderson FA, Wyman A, Greenspan SL, LaCroix AZ, Nieves JW, Silverman SL, Siris ES, Watts NB, Miller MJ, Curtis JR, Warriner AH, Wright NC, Saag KG. Evaluation of a Multimodal, Direct-to-Patient Educational Intervention Targeting Barriers to Osteoporosis Care: A Randomized Clinical Trial. J Bone Miner Res. 2018 May;33(5):763-772. doi: 10.1002/jbmr.3395. Epub 2018 Feb 26.
Results Reference
result

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A Direct-to-patient Intervention to Increase Rates of Osteoporosis Care

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