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Education for Osteoporosis in Persons With Existing Fractures

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Osteoporosis Prevention and Self-Management Course
Introductory education session on osteoporosis
Sponsored by
University of Adelaide
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Osteoporosis focused on measuring Osteoporosis/prevention & control, Osteoporosis Prevention and Self-Management Course, Patient Education/*trends//Questionnaires, Adult//Aged//Middle Aged, Life Style//

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Presented to Modbury Hospital's Accident and Emergency Department with a new bone fracture

Exclusion Criteria:

  • Residence in nursing home
  • Fracture sustained in motor bike, push bike or motor vehicle accident
  • Fracture sustained due to high trauma, such as fall from roof or ladder
  • Dementia
  • Inability to participate in group settings
  • Inability to understand spoken English
  • Inability to provide informed consent
  • Pathological fracture
  • Usual place of residence outside South Australia

Sites / Locations

  • Modbury Hospital, Modbury

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Osteoporosis Prevention and Self-Management Course (4 x 2 1/2 hours)

One "introductory" osteoporosis education session (1 x 2 1/2 hours)

Outcomes

Primary Outcome Measures

Difference between groups at three months on osteoporosis knowledge, confidence in ability to consume calcium and to exercise, actual calcium consumption and exercise levels

Secondary Outcome Measures

Changes between baseline and three months within each group on osteoporosis knowledge, confidence in the ability to each calcium-containing foods and exercise, and the amount of calcium consumed in foods and exercise undertaken

Full Information

First Posted
December 17, 2007
Last Updated
December 17, 2007
Sponsor
University of Adelaide
Collaborators
Osteoporosis SA
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1. Study Identification

Unique Protocol Identification Number
NCT00575250
Brief Title
Education for Osteoporosis in Persons With Existing Fractures
Official Title
Osteoporosis Education Clinic Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Adelaide
Collaborators
Osteoporosis SA

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
We wish to investigate whether a weekly, 2½ hour group-based osteoporosis education intervention (the Osteoporosis Prevention and Self-Management Course), is different to one session course (1x 2½ hours) on osteoporosis knowledge, confidence to eat calcium-containing foods, confidence to exercise, and amount of exercise undertaken after three and nine months of follow-up in people aged over 50 years who have already had a bone fracture.
Detailed Description
Instruments used to determine change after 3 and 9 months: Osteoporosis knowledge: Osteoporosis Knowledge Assessment Test (Winzenberg et al. BMC Musculoskelet Disord 2003) Calcium intake: Food frequency questionnaire (Angus et al. J Am Diet Assoc 1989) Calcium and exercise self-efficacy: Osteoporosis Self-Efficacy Scale (Horan et al Res Nurs Health 1998) Physical activity: CHAMPS II (Stewart et al. J Gerontol A Biol Sci Med Sci 2001)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Osteoporosis/prevention & control, Osteoporosis Prevention and Self-Management Course, Patient Education/*trends//Questionnaires, Adult//Aged//Middle Aged, Life Style//

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Osteoporosis Prevention and Self-Management Course (4 x 2 1/2 hours)
Arm Title
2
Arm Type
Active Comparator
Arm Description
One "introductory" osteoporosis education session (1 x 2 1/2 hours)
Intervention Type
Behavioral
Intervention Name(s)
Osteoporosis Prevention and Self-Management Course
Intervention Description
Four weekly education sessions of 2 1/2 hours duration, in a group session facilitated by a community nurse and trained lay leader.
Intervention Type
Behavioral
Intervention Name(s)
Introductory education session on osteoporosis
Intervention Description
Introductory education session, 1 x 2 1/2 hours in a group session facilitated by a community nurse and trained lay person.
Primary Outcome Measure Information:
Title
Difference between groups at three months on osteoporosis knowledge, confidence in ability to consume calcium and to exercise, actual calcium consumption and exercise levels
Time Frame
Three and nine months
Secondary Outcome Measure Information:
Title
Changes between baseline and three months within each group on osteoporosis knowledge, confidence in the ability to each calcium-containing foods and exercise, and the amount of calcium consumed in foods and exercise undertaken
Time Frame
Three and nine months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presented to Modbury Hospital's Accident and Emergency Department with a new bone fracture Exclusion Criteria: Residence in nursing home Fracture sustained in motor bike, push bike or motor vehicle accident Fracture sustained due to high trauma, such as fall from roof or ladder Dementia Inability to participate in group settings Inability to understand spoken English Inability to provide informed consent Pathological fracture Usual place of residence outside South Australia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura L Laslett, MMedSci
Organizational Affiliation
University of Adelaide
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julian D McNeil, PhD FRACP
Organizational Affiliation
University of Adelaide
Official's Role
Study Chair
Facility Information:
Facility Name
Modbury Hospital, Modbury
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5092
Country
Australia

12. IPD Sharing Statement

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Education for Osteoporosis in Persons With Existing Fractures

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