OsteoporosisNCT02445664
Effect of a Tablet-administered Educational Video on Patients´ Knowledge on Osteoporosis and Treatment
A study testing Educational video in people with Osteoporosis, run by University of Southern Denmark.
Trial summary
Osteoporosis is a highly prevalent disease in which non-adherence is a well-recognized problem. Non-adherence may be due to patients´ lack of knowledge, understanding, and involvement. In this study the investigators aimed to determine the effect of an educational video displayed on a tablet-device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Educational video
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for at DXA scan at the osteoporosis clinic
- Currently on once-weekly alendronate treatment
- Informed consent
Who cannot join
- Patients that do not understand Danish
- Patients having hearing impairments (unable to hear the video)
- Patients having visual impairments (unable to watch the video)
- Patients diagnosed with dementia
- Patients unable to give written informed consent.
About this study
Official title: Effect of a Tablet-administered Educational Video on Patients´ Knowledge on Osteoporosis and Treatment - a Randomized, Controlled Trial
Osteoporosis is a highly prevalent disease in which non-adherence is a well-recognized problem. Non-adherence may be due to patients´ lack of knowledge, understanding, and involvement. In this study the investigators aimed to determine the effect of an educational video displayed on a tablet-device. The investigators hypothesized that an educational video would increase patients´ knowledge on osteoporosis and treatment at a two week follow up.
- Conditions
- Osteoporosis
- Being tested
- Educational video
- Keywords
- Patient education, Video intervention
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videoBehavioural
Video: Information on osteoporosis and alendronate treatment.
| Study group | Role | What they receive |
|---|---|---|
| Video intervention | Experimental | A tablet-administered educational video (10 minutes duration). Receives: Behavioral: Educational video |
| Control | No intervention | No intervention (no video) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knowledge score
Measured: Baseline and 2-week follow up
Secondary outcomes (3)
Change in "confidence to treatment" score, as indicated by participant response to questionnaire.
Measured on a scale from 1-10
Measured: Baseline and 2-week follow up
Change in "satisfaction with the amount of information" score, as indicated by participant response to questionnaire.
Measured on a scale from 1-10
Measured: Baseline and 2-week follow up
Change in "understandability of the information" score, as indicated by participants response to questionnaire.
Measured on a scale from 1-10
Measured: Baseline and 2-week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startAug 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Principal investigator, Kirsa Skov, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445664
- Sponsor's protocol ID
- OP_77
- Status last verified
- May 2015
- First submitted
- 8 May 2015
- Last updated
- 15 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Tablet-administered Educational Video on Patients´ Knowledge on Osteoporosis and Treatment - a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02445664
- Acronym / sponsor ID
- OP_77
- Conditions
- Osteoporosis
- Keywords
- Patient education, Video intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- Aug 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 15 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoporosis is a highly prevalent disease in which non-adherence is a well-recognized problem. Non-adherence may be due to patients´ lack of knowledge, understanding, and involvement. In this study the investigators aimed to determine the effect of an educational video displayed on a tablet-device. The investigators hypothesized that an educational video would increase patients´ knowledge on osteoporosis and treatment at a two week follow up.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video intervention | Experimental | Behavioral: Educational videoA tablet-administered educational video (10 minutes duration). |
| Control | No intervention | –No intervention (no video) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled for at DXA scan at the osteoporosis clinic
- Currently on once-weekly alendronate treatment
- Informed consent
Key exclusion criteria (5 listed)
- Patients that do not understand Danish
- Patients having hearing impairments (unable to hear the video)
- Patients having visual impairments (unable to watch the video)
- Patients diagnosed with dementia
- Patients unable to give written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational videoVideo: Information on osteoporosis and alendronate treatment. | Behavioural | Video intervention |
Primary outcome
Change in knowledge score
Time frame: Baseline and 2-week follow up
3 secondary outcomes
Change in "confidence to treatment" score, as indicated by participant response to questionnaire.
Time frame: Baseline and 2-week follow up
Change in "satisfaction with the amount of information" score, as indicated by participant response to questionnaire.
Time frame: Baseline and 2-week follow up
Change in "understandability of the information" score, as indicated by participants response to questionnaire.
Time frame: Baseline and 2-week follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Educational video in people with Osteoporosis, run by University of Southern Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in knowledge score (time frame: Baseline and 2-week follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2015.