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

January 2, 2018 updated by: McMaster University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Osteoporosis Clininc affiliated to St. Joseph's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HAPA menu-based mini-video
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
The intervention will be a multi-target menu-based mini-videos designed to deliver information about vitamin D adherence and its effect on osteoporosis
ACTIVE_COMPARATOR: Standard care
This group will be advised by the treating physician to take vitamin D
Behavioral: Standard care
The treating physician will advice participants to take vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: 6 months
The ability to recruit 20 participants
6 months
Feedback of participants about the mini-videos
Time Frame: 5 minutes
A feedback form will be applied to participants within 5 minutes of watching the videos (the intervention)
5 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum level of vitamin D
Time Frame: after 3 months
after 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Investigators

  • Study Chair: Norma J. MacIntyre, PT, PhD, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

January 28, 2015

First Submitted That Met QC Criteria

February 3, 2015

First Posted (ESTIMATE)

February 9, 2015

Study Record Updates

Last Update Posted (ACTUAL)

January 3, 2018

Last Update Submitted That Met QC Criteria

January 2, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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