Osteoporosis
Conditions
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.
Interventions
BEHAVIORALVideo-based Intervention
Video clips delivered by DVD and Internet
Sponsors
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
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Self-reported history of fracture
Exclusion criteria
* Self-reported current prescription osteoporosis treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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
| Measure | Time frame |
|---|---|
| Number of Participants Who Reported Communicating With a Health Care Provider About Osteoporosis Care | 6 and 18 months post-intervention |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 1,342 |
| Usual Care | 1,342 |
| Total | 2,684 |
Baseline characteristics
| Characteristic | Usual Care | Total | Video-based Intervention |
|---|---|---|---|
| Age, Continuous | 74.9 years STANDARD_DEVIATION 7.9 | 74.9 years STANDARD_DEVIATION 7.96 | 74.9 years STANDARD_DEVIATION 8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 46 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1321 Participants | 2638 Participants | 1317 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Number of Participants who Completed Barriers to Osteoporosis Treatment | 0 Participants | 482 Participants | 482 Participants |
| Number of Participants who completed Patient's Views about Osteoporosis and Use of Therapy Scale | 0 Participants | 429 Participants | 429 Participants |
| Number of Participants who Completed Readiness to Behavior Change | 0 Participants | 300 Participants | 300 Participants |
| Number of Participants who Completed the Osteoporosis Treatment History (tailoring) | 0 Participants | 131 Participants | 131 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 26 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 52 Participants | 98 Participants | 46 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 38 Participants | 74 Participants | 36 Participants |
| Race (NIH/OMB) White | 1239 Participants | 2486 Participants | 1247 Participants |
| Region of Enrollment United States | 1342 Participants | 2684 Participants | 1342 Participants |
| Sex: Female, Male Female | 1342 Participants | 2684 Participants | 1342 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: 6 months post-intervention
Population: For the Intent-to-Treat Analysis the data was imputed for non-responders.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Video-based Intervention | Number of Participants That Initiate an Osteoporosis Prescription Medication | 157 Participants |
| Usual Care | Number of Participants That Initiate an Osteoporosis Prescription Medication | 153 Participants |
Secondary
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.
Time frame: 18 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Video-based Intervention | Number of Participants That Initiate an Osteoporosis Prescription Medication | 136 Participants |
| Usual Care | Number of Participants That Initiate an Osteoporosis Prescription Medication | 131 Participants |
Secondary
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).
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Video-based Intervention | Number of Participants Who Reported Receipt of Bone Mineral Density (BMD) Testing | BMD (18 months) | 530 Participants |
| Video-based Intervention | Number of Participants Who Reported Receipt of Bone Mineral Density (BMD) Testing | BMD (6 months) | 290 Participants |
| Usual Care | Number of Participants Who Reported Receipt of Bone Mineral Density (BMD) Testing | BMD (6 months) | 268 Participants |
| Usual Care | Number of Participants Who Reported Receipt of Bone Mineral Density (BMD) Testing | BMD (18 months) | 522 Participants |
Secondary
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.
Time frame: 6 and 18 months post-intervention
Population: For the Intent-to-Treat Analysis the data was imputed for non-responders.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Video-based Intervention | Number of Participants Who Reported Use of Calcium and Vitamin D | Vitamin D (6 months) | 554 Participants |
| Video-based Intervention | Number of Participants Who Reported Use of Calcium and Vitamin D | Calcium (6 months) | 427 Participants |
| Video-based Intervention | Number of Participants Who Reported Use of Calcium and Vitamin D | Vitamin D (18 months) | 475 Participants |
| Video-based Intervention | Number of Participants Who Reported Use of Calcium and Vitamin D | Calcium (18 months) | 249 Participants |
| Usual Care | Number of Participants Who Reported Use of Calcium and Vitamin D | Calcium (18 months) | 310 Participants |
| Usual Care | Number of Participants Who Reported Use of Calcium and Vitamin D | Vitamin D (6 months) | 562 Participants |
| Usual Care | Number of Participants Who Reported Use of Calcium and Vitamin D | Vitamin D (18 months) | 572 Participants |
| Usual Care | Number of Participants Who Reported Use of Calcium and Vitamin D | Calcium (6 months) | 437 Participants |
Other Pre-specified
Number of Participants Who Reported Communicating With a Health Care Provider About Osteoporosis Care
Time frame: 6 and 18 months post-intervention
Population: For the Intent-to-Treat Analysis the data was imputed for non-responders.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Video-based Intervention | Number of Participants Who Reported Communicating With a Health Care Provider About Osteoporosis Care | Bone health discussion w/provider (6 months) | 583 Participants |
| Video-based Intervention | Number of Participants Who Reported Communicating With a Health Care Provider About Osteoporosis Care | Bone health discussion w/provider (18 months) | 779 Participants |
| Usual Care | Number of Participants Who Reported Communicating With a Health Care Provider About Osteoporosis Care | Bone health discussion w/provider (6 months) | 573 Participants |
| Usual Care | Number of Participants Who Reported Communicating With a Health Care Provider About Osteoporosis Care | Bone health discussion w/provider (18 months) | 806 Participants |