NCT02358590

Brief Summary

This pilot study evaluates the effect of theory menu-based mini-videos on vitamin D adherence in older adult with osteoporosis. Half of participants will watch the videos while the other half will receive usual care (treating physician advice).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 3, 2018

Status Verified

January 1, 2018

Enrollment Period

2.8 years

First QC Date

January 28, 2015

Last Update Submit

January 2, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Recruitment rate

    The ability to recruit 20 participants

    6 months

  • Feedback of participants about the mini-videos

    A feedback form will be applied to participants within 5 minutes of watching the videos (the intervention)

    5 minutes

Secondary Outcomes (1)

  • Serum level of vitamin D

    after 3 months

Study Arms (2)

HAPA menu-based mini-video

EXPERIMENTAL

This group will watch mini-videos, which are multi-target menu-based interventions designed to deliver information about vitamin D adherence and its effect on osteoporosis

Behavioral: HAPA menu-based mini-video

Standard care

ACTIVE COMPARATOR

This group will be advised by the treating physician to take vitamin D

Behavioral: Standard care

Interventions

The intervention will be a multi-target menu-based mini-videos designed to deliver information about vitamin D adherence and its effect on osteoporosis

HAPA menu-based mini-video
Standard careBEHAVIORAL

The treating physician will advice participants to take vitamin D

Standard care

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over the age of 50 years
  • Have been diagnosed with primary osteoporosis
  • Have low vitamin D level (less than 75nmol/L) recently (within the previous month)
  • Fluent in English

You may not qualify if:

  • Cognitive diseases
  • Mal-absorption syndromes that may interfere with vitamin D absorption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osteoporosis Clininc affiliated to St. Joseph's Hospital

Hamilton, Ontario, L8N 1Y2, Canada

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Norma J. MacIntyre, PT, PhD

    McMaster University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 9, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 3, 2018

Record last verified: 2018-01

Locations