NCT02445664

Brief 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. The investigators hypothesized that an educational video would increase patients´ knowledge on osteoporosis and treatment at a two week follow up.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
Last Updated

May 15, 2015

Status Verified

May 1, 2015

Enrollment Period

3 months

First QC Date

May 8, 2015

Last Update Submit

May 12, 2015

Conditions

Osteoporosis

Keywords

Patient educationVideo intervention

Outcome Measures

Primary Outcomes (1)

  • Change in knowledge score

    Baseline and 2-week follow up

Secondary Outcomes (3)

  • Change in "confidence to treatment" score, as indicated by participant response to questionnaire.

    Baseline and 2-week follow up

  • Change in "satisfaction with the amount of information" score, as indicated by participant response to questionnaire.

    Baseline and 2-week follow up

  • Change in "understandability of the information" score, as indicated by participants response to questionnaire.

    Baseline and 2-week follow up

Study Arms (2)

Video intervention

EXPERIMENTAL

A tablet-administered educational video (10 minutes duration).

Behavioral: Educational video

Control

NO INTERVENTION

No intervention (no video)

Interventions

Educational videoBEHAVIORAL

Video: Information on osteoporosis and alendronate treatment.

Video intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for at DXA scan at the osteoporosis clinic
  • Currently on once-weekly alendronate treatment
  • Informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student, pharmacist

Study Record Dates

First Submitted

May 8, 2015

First Posted

May 15, 2015

Study Start

August 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

May 15, 2015

Record last verified: 2015-05