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

NCT ID: NCT02358590

Last Updated: 2018-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

HAPA menu-based mini-video

Intervention Type BEHAVIORAL

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

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

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type BEHAVIORAL

The treating physician will advice participants to take vitamin D

Interventions

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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

Intervention Type BEHAVIORAL

Standard care

The treating physician will advice participants to take vitamin D

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Norma J. MacIntyre, PT, PhD

Role: STUDY_CHAIR

McMaster University

Locations

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Osteoporosis Clininc affiliated to St. Joseph's Hospital

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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15-026

Identifier Type: -

Identifier Source: org_study_id

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