The Effect of Theory Menu-Based Intervention on Vitamin D Adherence in People With Osteoporosis-Pilot Study

Osteoporosis Clinical Trial

Official title:

The Effect of Health Action Process Approach Menu-Based Intervention on Vitamin D Adherence in Older Adult With Osteoporosis-Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02358590
• Other study ID #: 15-026
• Status: Completed
• Phase: N/A
• First received: January 28, 2015
• Last updated: January 2, 2018
• Start date: February 2015
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Behavioral:
• HAPA menu-based mini-video
The intervention will be a multi-target menu-based mini-videos designed to deliver information about vitamin D adherence and its effect on osteoporosis
• Standard care
The treating physician will advice participants to take vitamin D

Locations

Country	Name	City	State
Canada	Osteoporosis Clininc affiliated to St. Joseph's Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	The ability to recruit 20 participants	6 months
Primary	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	Serum level of vitamin D		after 3 months