Education for Osteoporosis in Persons With Existing Fractures

This study has been completed.
Sponsor:
Collaborator:
Osteoporosis SA
Information provided by:
University of Adelaide
ClinicalTrials.gov Identifier:
NCT00575250
First received: December 17, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Osteoporosis
Behavioral: Osteoporosis Prevention and Self-Management Course
Behavioral: Introductory education session on osteoporosis

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Osteoporosis Education Clinic Study

Resource links provided by NLM:


Further study details as provided by University of Adelaide:

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 [ Time Frame: Three and nine months ] [ Designated as safety issue: No ]

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 [ Time Frame: Three and nine months ] [ Designated as safety issue: No ]

Enrollment: 152
Study Start Date: January 2004
Study Completion Date: December 2007
Arms Assigned Interventions
Active Comparator: 1
Osteoporosis Prevention and Self-Management Course (4 x 2 1/2 hours)
Behavioral: Osteoporosis Prevention and Self-Management Course
Four weekly education sessions of 2 1/2 hours duration, in a group session facilitated by a community nurse and trained lay leader.
Active Comparator: 2
One "introductory" osteoporosis education session (1 x 2 1/2 hours)
Behavioral: Introductory education session on osteoporosis
Introductory education session, 1 x 2 1/2 hours in a group session facilitated by a community nurse and trained lay person.

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)

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575250

Locations
Australia, South Australia
Modbury Hospital, Modbury
Adelaide, South Australia, Australia, 5092
Sponsors and Collaborators
University of Adelaide
Osteoporosis SA
Investigators
Principal Investigator: Laura L Laslett, MMedSci University of Adelaide
Study Chair: Julian D McNeil, PhD FRACP University of Adelaide
  More Information

No publications provided

Responsible Party: Ms Laura Laslett, University of Adelaide
ClinicalTrials.gov Identifier: NCT00575250     History of Changes
Other Study ID Numbers: 2.180405
Study First Received: December 17, 2007
Last Updated: December 17, 2007
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by University of Adelaide:
Osteoporosis/prevention & control
Osteoporosis Prevention and Self-Management Course
Patient Education/*trends//Questionnaires
Adult//Aged//Middle Aged
Life Style//

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 26, 2014