Back to resultsThe Effect of Theory Menu-Based Intervention on Vitamin D Adherence in People With Osteoporosis-Pilot Study
Primary Purpose
Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
HAPA menu-based mini-video
Standard care
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Cognitive diseases
- Mal-absorption syndromes that may interfere with vitamin D absorption.
Sites / Locations
- Osteoporosis Clininc affiliated to St. Joseph's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HAPA menu-based mini-video
Standard care
Arm Description
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
This group will be advised by the treating physician to take vitamin D
Outcomes
Primary Outcome Measures
Recruitment rate
The ability to recruit 20 participants
Feedback of participants about the mini-videos
A feedback form will be applied to participants within 5 minutes of watching the videos (the intervention)
Secondary Outcome Measures
Serum level of vitamin D
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02358590
Brief Title
The Effect of Theory Menu-Based Intervention on Vitamin D Adherence in People With Osteoporosis-Pilot Study
Official Title
The Effect of Health Action Process Approach Menu-Based Intervention on Vitamin D Adherence in Older Adult With Osteoporosis-Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
Detailed Description
Osteoporosis is a common disease around the world. The morbidity and mortality attributed to osteoporosis is due to fracture. The evidence shows that vitamin D is effective in preventing osteoporotic fracture, however, adherence to vitamin D is low among people with osteoporosis (20%-60%). The Health Action Process Approach (HAPA) has been found useful to describe, explain, and predict changes in health behaviours in a variety of setting. Based on HAPA, mini-videos will be developed aiming to increase vitamin D adherence in people with osteoporosis. Mini-videos will address self-efficacy, outcome expectancy, risk perception and action and coping plan. This pilot study aims to evaluate the recruitment and participants' feedback about the mini-videos.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HAPA menu-based mini-video
Arm Type
Experimental
Arm Description
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
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
This group will be advised by the treating physician to take vitamin D
Intervention Type
Behavioral
Intervention Name(s)
HAPA menu-based mini-video
Intervention Description
The intervention will be a multi-target menu-based mini-videos designed to deliver information about vitamin D adherence and its effect on osteoporosis
Intervention Type
Behavioral
Intervention Name(s)
Standard care
Intervention Description
The treating physician will advice participants to take vitamin D
Primary Outcome Measure Information:
Title
Recruitment rate
Description
The ability to recruit 20 participants
Time Frame
6 months
Title
Feedback of participants about the mini-videos
Description
A feedback form will be applied to participants within 5 minutes of watching the videos (the intervention)
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Serum level of vitamin D
Time Frame
after 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Cognitive diseases
Mal-absorption syndromes that may interfere with vitamin D absorption.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norma J. MacIntyre, PT, PhD
Organizational Affiliation
McMaster University
Official's Role
Study Chair
Facility Information:
Facility Name
Osteoporosis Clininc affiliated to St. Joseph's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
The Effect of Theory Menu-Based Intervention on Vitamin D Adherence in People With Osteoporosis-Pilot Study
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