Trial Outcomes & Findings for A Direct-to-patient Intervention to Increase Rates of Osteoporosis Care (NCT NCT01907269)

NCT ID: NCT01907269

Last Updated: 2018-06-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

2684 participants

Primary outcome timeframe

6 months post-intervention

Results posted on

2018-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	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. Video-based Intervention: Video clips delivered by DVD and Internet	Usual Care
6 Month Outcome Measures Post-interventi STARTED	1342	1342
6 Month Outcome Measures Post-interventi COMPLETED	953	1053
6 Month Outcome Measures Post-interventi NOT COMPLETED	389	289
18 Month Outcome Measures Post-intervent STARTED	1178	1250
18 Month Outcome Measures Post-intervent COMPLETED	859	970
18 Month Outcome Measures Post-intervent NOT COMPLETED	319	280

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 6 months post-intervention

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

Outcome measures

Outcome measures
Measure	Video-based Intervention n=1342 Participants 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	Usual Care n=1342 Participants
Number of Participants That Initiate an Osteoporosis Prescription Medication	157 Participants	153 Participants

SECONDARY outcome

Timeframe: 6 and 18 months post-intervention

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

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.

Outcome measures

Outcome measures
Measure	Video-based Intervention n=1342 Participants 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	Usual Care n=1342 Participants
Number of Participants Who Reported Use of Calcium and Vitamin D Vitamin D (6 months)	554 Participants	562 Participants
Number of Participants Who Reported Use of Calcium and Vitamin D Calcium (6 months)	427 Participants	437 Participants
Number of Participants Who Reported Use of Calcium and Vitamin D Vitamin D (18 months)	475 Participants	572 Participants
Number of Participants Who Reported Use of Calcium and Vitamin D Calcium (18 months)	249 Participants	310 Participants

SECONDARY outcome

Timeframe: 6 and 18 months post-intervention

Population: 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.

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

Outcome measures

Outcome measures
Measure	Video-based Intervention n=1342 Participants 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	Usual Care n=1342 Participants
Number of Participants Who Reported Receipt of Bone Mineral Density (BMD) Testing BMD (6 months)	290 Participants	268 Participants
Number of Participants Who Reported Receipt of Bone Mineral Density (BMD) Testing BMD (18 months)	530 Participants	522 Participants

SECONDARY outcome

Timeframe: 18 months

Outcome measures

Outcome measures
Measure	Video-based Intervention n=1178 Participants 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	Usual Care n=1250 Participants
Number of Participants That Initiate an Osteoporosis Prescription Medication	136 Participants	131 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 and 18 months post-intervention

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

Outcome measures

Outcome measures
Measure	Video-based Intervention n=1342 Participants 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	Usual Care n=1342 Participants
Number of Participants Who Reported Communicating With a Health Care Provider About Osteoporosis Care Bone health discussion w/provider (6 months)	583 Participants	573 Participants
Number of Participants Who Reported Communicating With a Health Care Provider About Osteoporosis Care Bone health discussion w/provider (18 months)	779 Participants	806 Participants

Adverse Events

Video-based Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Elizabeth J. Rahn

University of Alabama at Birmingham

Phone: 2059966552

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Video-based Intervention n=1342 Participants 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	Usual Care n=1342 Participants	Total n=2684 Participants Total of all reporting groups
Age, Continuous	74.9 years STANDARD_DEVIATION 8 • n=1342 Participants	74.9 years STANDARD_DEVIATION 7.9 • n=1342 Participants	74.9 years STANDARD_DEVIATION 7.96 • n=2684 Participants
Sex: Female, Male Female	1342 Participants n=1342 Participants	1342 Participants n=1342 Participants	2684 Participants n=2684 Participants
Sex: Female, Male Male	0 Participants n=1342 Participants	0 Participants n=1342 Participants	0 Participants n=2684 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=1342 Participants	21 Participants n=1342 Participants	46 Participants n=2684 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1317 Participants n=1342 Participants	1321 Participants n=1342 Participants	2638 Participants n=2684 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=1342 Participants	0 Participants n=1342 Participants	0 Participants n=2684 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=1342 Participants	0 Participants n=1342 Participants	0 Participants n=2684 Participants
Race (NIH/OMB) Asian	13 Participants n=1342 Participants	13 Participants n=1342 Participants	26 Participants n=2684 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=1342 Participants	0 Participants n=1342 Participants	0 Participants n=2684 Participants
Race (NIH/OMB) Black or African American	46 Participants n=1342 Participants	52 Participants n=1342 Participants	98 Participants n=2684 Participants
Race (NIH/OMB) White	1247 Participants n=1342 Participants	1239 Participants n=1342 Participants	2486 Participants n=2684 Participants
Race (NIH/OMB) More than one race	0 Participants n=1342 Participants	0 Participants n=1342 Participants	0 Participants n=2684 Participants
Race (NIH/OMB) Unknown or Not Reported	36 Participants n=1342 Participants	38 Participants n=1342 Participants	74 Participants n=2684 Participants
Region of Enrollment United States	1342 Participants n=1342 Participants	1342 Participants n=1342 Participants	2684 Participants n=2684 Participants
Number of Participants who Completed Barriers to Osteoporosis Treatment	482 Participants n=1342 Participants • 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.	0 Participants 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.	482 Participants n=1342 Participants • 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	429 Participants n=1342 Participants • 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.	0 Participants 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.	429 Participants n=1342 Participants • 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	300 Participants n=1342 Participants • 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.	0 Participants 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.	300 Participants n=1342 Participants • 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)	131 Participants n=1342 Participants • 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.	0 Participants 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.	131 Participants n=1342 Participants • 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.