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Trial record 80 of 231 for:    CALCITONIN SALMON

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01907269
Recruitment Status : Completed
First Posted : July 24, 2013
Results First Posted : June 26, 2018
Last Update Posted : June 26, 2018
Sponsor:
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
Information provided by (Responsible Party):
Kenneth Saag, MD, MSc, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Prevention
Condition Osteoporosis
Intervention Behavioral: Video-based Intervention
Enrollment 2684
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Video-based Intervention Usual Care
Hide 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

[Not Specified]
Period Title: 6 Month Outcome Measures Post-interventi
Started 1342 1342
Completed 953 1053
Not Completed 389 289
Period Title: 18 Month Outcome Measures Post-intervent
Started 1178 1250
Completed 859 970
Not Completed 319 280
Arm/Group Title Video-based Intervention Usual Care Total
Hide 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

[Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 1342 1342 2684
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1342 participants 1342 participants 2684 participants
74.9  (8) 74.9  (7.9) 74.9  (7.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1342 participants 1342 participants 2684 participants
Female
1342
 100.0%
1342
 100.0%
2684
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1342 participants 1342 participants 2684 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%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1342 participants 1342 participants 2684 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
13
   1.0%
13
   1.0%
26
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
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%
0
   0.0%
Unknown or Not Reported
36
   2.7%
38
   2.8%
74
   2.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 1342 participants 1342 participants 2684 participants
1342
 100.0%
1342
 100.0%
2684
 100.0%
Number of Participants who Completed Barriers to Osteoporosis Treatment   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1342 participants 0 participants 1342 participants
482
  35.9%
0
482
  35.9%
[1]
Measure Description: A list of seven potentially modifiable barriers was presented to patients in the baseline survey. Those that ranked them in the intervention arm (N=482) were allocated a tailored online and video intervention based on their response. Unfortunately, not all participants ranked barriers (i.e., they didn't follow the survey directions). Individuals that did not rank barriers received an intervention corresponding to the next level of tailoring (e.g., Responses on the Patient's Views about Osteoporosis Use and Therapy Scale, Readiness to Behavior Change, or Osteoporosis treatment history).
[2]
Measure Analysis Population Description: Data were only evaluated for intervention tailoring on the "Video-based intervention" arm. "Usual care" data on this measure was not evaluated for the purposes of tailoring, therefore the Row population consists only of the intervention arm (n=1342) and does not include usual care. This results in the row population differing from overall.
Number of Participants who completed Patient's Views about Osteoporosis and Use of Therapy Scale   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1342 participants 0 participants 1342 participants
429
  32.0%
0
429
  32.0%
[1]
Measure Description: Patients in the "Video-based intervention" arm that didn't rank barriers, but who did complete the Patient's Views about Osteoporosis and Use of Therapy Scale (N=429) received a tailored intervention based on responses to this scale. Unfortunately, not all participants completed the Patient's Views about Osteoporosis and Use of Therapy Scale (i.e., they didn't follow the survey directions); these individuals received an intervention corresponding to the next level of tailoring (e.g., Readiness to Behavior Change, or Osteoporosis treatment history).
[2]
Measure Analysis Population Description: Data were only evaluated for intervention tailoring on the "Video-based intervention" arm. "Usual care" data on this measure was not evaluated for the purposes of tailoring, therefore the Row population consists only of the intervention arm (n=1342) and does not include usual care. This results in the row population differing from overall.
Number of Participants who Completed Readiness to Behavior Change   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1342 participants 0 participants 1342 participants
300
  22.4%
0
300
  22.4%
[1]
Measure Description: Patients in the "Video-based intervention" arm that didn't rank barriers,and did not complete the Patient's Views about Osteoporosis and Use of Therapy Scale received a tailored intervention based on their readiness to behavior change (N=300) as assessed by a modified version of Weinstein's Precaution Adoption Process Model. Unfortunately, not all participants completed the Readiness to Behavior Change (i.e., they didn't follow the survey directions); these individuals received an intervention corresponding to the next level of tailoring (e.g., Osteoporosis treatment history).
[2]
Measure Analysis Population Description: Data were only evaluated for intervention tailoring on the "Video-based intervention" arm. "Usual care" data on this measure was not evaluated for the purposes of tailoring, therefore the Row population consists only of the intervention arm (n=1342) and does not include usual care. This results in the row population differing from overall.
Number of Participants who Completed the Osteoporosis Treatment History (tailoring)   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1342 participants 0 participants 1342 participants
131
   9.8%
0
131
   9.8%
[1]
Measure Description: Patients in the "Video-based intervention" arm that didn't rank barriers, did not complete the Patient's Views about Osteoporosis and Use of Therapy Scale, and where readiness to behavior change could not be assessed received an intervention tailored based on their osteoporosis treatment history as assessed by our survey (N=131). The categorization for this variable was dichotomous, those that indicated they had received previous treatment or those that indicated they had not received previous treatment.
[2]
Measure Analysis Population Description: Data were only evaluated for intervention tailoring on the "Video-based intervention" arm. "Usual care" data on this measure was not evaluated for the purposes of tailoring, therefore the Row population consists only of the intervention arm (n=1342) and does not include usual care. This results in the row population differing from overall.
1.Primary Outcome
Title Number of Participants That Initiate an Osteoporosis Prescription Medication
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
For the Intent-to-Treat Analysis the data was imputed for non-responders.
Arm/Group Title Video-based Intervention Usual Care
Hide 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

[Not Specified]
Overall Number of Participants Analyzed 1342 1342
Measure Type: Count of Participants
Unit of Measure: Participants
157
  11.7%
153
  11.4%
2.Secondary Outcome
Title Number of Participants Who Reported Use of Calcium and Vitamin D
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
For the Intent-to-Treat Analysis the data was imputed for non-responders.
Arm/Group Title Video-based Intervention Usual Care
Hide 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

[Not Specified]
Overall Number of Participants Analyzed 1342 1342
Measure Type: Count of Participants
Unit of Measure: Participants
Vitamin D (6 months) Number Analyzed 1342 participants 1342 participants
554
  41.3%
562
  41.9%
Calcium (6 months) Number Analyzed 1342 participants 1342 participants
427
  31.8%
437
  32.6%
Vitamin D (18 months) Number Analyzed 1178 participants 1250 participants
475
  40.3%
572
  45.8%
Calcium (18 months) Number Analyzed 1178 participants 1250 participants
249
  21.1%
310
  24.8%
3.Secondary Outcome
Title Number of Participants Who Reported Receipt of Bone Mineral Density (BMD) Testing
Hide Description Self-report of a receipt of a DXA scan (Bone Mineral Density test).
Time Frame 6 and 18 months post-intervention
Hide Outcome Measure Data
Hide 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
Hide 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

[Not Specified]
Overall Number of Participants Analyzed 1342 1342
Measure Type: Count of Participants
Unit of Measure: Participants
BMD (6 months) Number Analyzed 469 participants 469 participants
290
  61.8%
268
  57.1%
BMD (18 months) Number Analyzed 643 participants 663 participants
530
  82.4%
522
  78.7%
4.Secondary Outcome
Title Number of Participants That Initiate an Osteoporosis Prescription Medication
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Video-based Intervention Usual Care
Hide 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

[Not Specified]
Overall Number of Participants Analyzed 1178 1250
Measure Type: Count of Participants
Unit of Measure: Participants
136
  11.5%
131
  10.5%
5.Other Pre-specified Outcome
Title Number of Participants Who Reported Communicating With a Health Care Provider About Osteoporosis Care
Hide Description [Not Specified]
Time Frame 6 and 18 months post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
For the Intent-to-Treat Analysis the data was imputed for non-responders.
Arm/Group Title Video-based Intervention Usual Care
Hide 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

[Not Specified]
Overall Number of Participants Analyzed 1342 1342
Measure Type: Count of Participants
Unit of Measure: Participants
Bone health discussion w/provider (6 months) Number Analyzed 1342 participants 1342 participants
583
  43.4%
573
  42.7%
Bone health discussion w/provider (18 months) Number Analyzed 1178 participants 1250 participants
779
  66.1%
806
  64.5%
Time Frame [Not Specified]
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
Hide 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

[Not Specified]
All-Cause Mortality
Video-based Intervention Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Video-based Intervention Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Video-based Intervention Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Elizabeth J. Rahn
Organization: University of Alabama at Birmingham
Phone: 2059966552
EMail: rahneli@uab.edu
Layout table for additonal information
Responsible Party: Kenneth Saag, MD, MSc, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01907269     History of Changes
Other Study ID Numbers: X110928001
R01AR060240 ( U.S. NIH Grant/Contract )
First Submitted: July 11, 2013
First Posted: July 24, 2013
Results First Submitted: March 9, 2018
Results First Posted: June 26, 2018
Last Update Posted: June 26, 2018