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

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT01907269
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH), University of Massachusetts, Worcester (Other), Helen Hayes Hospital (Other), Kaiser Permanente (Other), Cedars-Sinai Medical Center (Other), University of Pittsburgh (Other), University of Cincinnati (Other)
• Enrollment: 2,684
• Locations: 7
• Arms: 2
• Duration (Months): 39
• Patients Per Site: 383.4
• Patients Per Site Per Month: 9.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Behavioral: Video-based Intervention	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 2684 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Prevention
• Official Title: Activating Patients to Reduce OsteoPOrosiS
• Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Video-based intervention 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.	Behavioral: Video-based Intervention; Video clips delivered by DVD and Internet
No Intervention: Usual care

Outcome Measures

Primary Outcome Measures

1. Number of Participants That Initiate an Osteoporosis Prescription Medication [6 months post-intervention]

   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

1. Number of Participants Who Reported Use of Calcium and Vitamin D [6 and 18 months post-intervention]

   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.

2. Number of Participants Who Reported Receipt of Bone Mineral Density (BMD) Testing [6 and 18 months post-intervention]

   Self-report of a receipt of a DXA scan (Bone Mineral Density test).

3. Number of Participants That Initiate an Osteoporosis Prescription Medication [18 months]

   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.

Other Outcome Measures

1. Number of Participants Who Reported Communicating With a Health Care Provider About Osteoporosis Care [6 and 18 months post-intervention]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Self-reported history of fracture

Exclusion Criteria:

• Self-reported current prescription osteoporosis treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35205
2	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
3	University of Massachusetts at Worcester	Worcester	Massachusetts	United States	01655
4	New York University	New York	New York	United States	10016
5	Jewish Hospital of Cincinnati	Cincinnati	Ohio	United States	45236
6	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
7	Group Health Research Institute	Seattle	Washington	United States	98101

Sponsors and Collaborators

• University of Alabama at Birmingham
• 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

Investigators

• Principal Investigator: Kenneth G Saag, MD, MSc, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

• Weinstein ND. The precaution adoption process. Health Psychol. 1988;7(4):355-86. Review.
• 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.

• Responsible Party: Kenneth Saag, MD, MSc, Professor of Medicine, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT01907269
• Other Study ID Numbers: X110928001; R01AR060240
• First Posted: Jul 24, 2013
• Last Update Posted: Jun 26, 2018
• Last Verified: May 1, 2018

• Additional relevant MeSH terms: Osteoporosis

Study Results

Participant Flow

Arm/Group Title	Video-based Intervention	Usual Care
Arm/Group 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. Video-based Intervention: Video clips delivered by DVD and Internet
Period Title: 6 Month Outcome Measures Post-interventi
STARTED	1342	1342
COMPLETED	953	1053
NOT COMPLETED	389	289
Period Title: 6 Month Outcome Measures Post-interventi
STARTED	1178	1250
COMPLETED	859	970
NOT COMPLETED	319	280

Baseline Characteristics

Arm/Group Title	Video-based Intervention	Usual Care	Total
Arm/Group 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. Video-based Intervention: Video clips delivered by DVD and Internet	Total of all reporting groups
Overall Participants	1342	1342	2684
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	74.9 (8)	74.9 (7.9)	74.9 (7.96)
Sex: Female, Male (Count of Participants)
Female	1342 100%	1342 100%	2684 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	25 1.9%	21 1.6%	46 1.7%
Not Hispanic or Latino	1317 98.1%	1321 98.4%	2638 98.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	13 1%	13 1%	26 1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	46 3.4%	52 3.9%	98 3.7%
White	1247 92.9%	1239 92.3%	2486 92.6%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	36 2.7%	38 2.8%	74 2.8%
Region of Enrollment (Count of Participants)
United States	1342 100%	1342 100%	2684 100%
Number of Participants who Completed Barriers to Osteoporosis Treatment (Count of Participants)
Count of Participants [Participants]	482 35.9%	0 0%	482 18%
Number of Participants who completed Patient's Views about Osteoporosis and Use of Therapy Scale (Count of Participants)
Count of Participants [Participants]	429 32%	0 0%	429 16%
Number of Participants who Completed Readiness to Behavior Change (Count of Participants)
Count of Participants [Participants]	300 22.4%	0 0%	300 11.2%
Number of Participants who Completed the Osteoporosis Treatment History (tailoring) (Count of Participants)
Count of Participants [Participants]	131 9.8%	0 0%	131 4.9%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

For the Intent-to-Treat Analysis the data was imputed for non-responders.

Arm/Group Title	Video-based Intervention	Usual Care
Arm/Group 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. Video-based Intervention: Video clips delivered by DVD and Internet
Measure Participants	1342	1342
Count of Participants [Participants]	157 11.7%	153 11.4%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

For the Intent-to-Treat Analysis the data was imputed for non-responders.

Arm/Group Title	Video-based Intervention	Usual Care
Arm/Group 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. Video-based Intervention: Video clips delivered by DVD and Internet
Measure Participants	1342	1342
Vitamin D (6 months)	554 41.3%	562 41.9%
Calcium (6 months)	427 31.8%	437 32.6%
Vitamin D (18 months)	475 35.4%	572 42.6%
Calcium (18 months)	249 18.6%	310 23.1%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

For the Intent-to-Treat Analysis the data was imputed for non-responders. Surveys for BMD (18 months) included 3 responses. If participants marked option (2) that they had received a BMD, but > 12 months ago they were excluded from analyses. Thus our overall population analyzed (those marking response 1 or 3) is different than our participant flow.

Arm/Group Title	Video-based Intervention	Usual Care
Arm/Group 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. Video-based Intervention: Video clips delivered by DVD and Internet
Measure Participants	1342	1342
BMD (6 months)	290 21.6%	268 20%
BMD (18 months)	530 39.5%	522 38.9%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Video-based Intervention	Usual Care
Arm/Group 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. Video-based Intervention: Video clips delivered by DVD and Internet
Measure Participants	1178	1250
Count of Participants [Participants]	136 10.1%	131 9.8%

5. Other Pre-specified Outcome

Title	Number of Participants Who Reported Communicating With a Health Care Provider About Osteoporosis Care
Time Frame	6 and 18 months post-intervention

Outcome Measure Data

Analysis Population Description

For the Intent-to-Treat Analysis the data was imputed for non-responders.

Arm/Group Title	Video-based Intervention	Usual Care
Arm/Group 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. Video-based Intervention: Video clips delivered by DVD and Internet
Measure Participants	1342	1342
Bone health discussion w/provider (6 months)	583 43.4%	573 42.7%
Bone health discussion w/provider (18 months)	779 58%	806 60.1%

Adverse Events

Adverse Event Reporting Description	All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed.
Arm/Group Title	Video-based Intervention		Usual Care
Arm/Group 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. Video-based Intervention: Video clips delivered by DVD and Internet
All Cause Mortality
	Video-based Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Video-based Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Video-based Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

Low rates of osteoporosis treatment initiation; Self-reported fracture history subject to recall bias; Low % of participants reported fracture in 12-months prior to intervention; Low % of participants who interacted with intervention appreciably

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.