Vitamin D Osteoporosis Long-Term Care Study (ViDOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01398527
Recruitment Status : Completed
First Posted : July 20, 2011
Last Update Posted : May 3, 2013
Information provided by (Responsible Party):
Alexandra Papaioannou, McMaster University

Brief Summary:
The research question is, does a multifaceted, multidisciplinary intervention including small groups, chart audits and point of care tools, increase the number of people receiving optimal vitamin D therapy in the long term care (LTC) setting? Secondary outcomes include the number of falls and fractures experienced by the residents in each LTC home and the number of residents receiving appropriate bisphosphonate therapy.

Condition or disease Intervention/treatment Phase
Osteoporosis Other: Educ sessions & LTC Osteoporosis toolkit Not Applicable

Detailed Description:

This is a cluster randomized controlled trial. In the long-term care (LTC) setting, more research is needed on how health care professionals can be kept up to date on the latest medical evidence for providing care to elderly residents. The LTC environment differs from other health care settings. We need to examine what types of strategies can be used to effectively educate LTC physicians, nurses, and other care professionals about the best care practices.

In this study, we will deliver and evaluate a multi-component educational strategy that builds on research in LTC by our team. In order to evaluate its success, 20 homes will receive the intervention and 20 homes will receive usual care. In the intervention homes, a team of experts will give educational sessions at the LTC home, delivering key messages about "best practices", helping LTC professionals to plan changes for delivering better care, giving feedback about performance, and providing materials (e.g., DVD, treatment plans). We will also train a professional in the home to "champion" the cause after the experts are gone.

The specific "best practices" topic we have chosen to test our model is osteoporosis and fractures. These conditions are very common in the elderly living in LTC and negatively impact quality of life. For example, an individual with a hip or other fracture may experience unnecessary pain and suffering and even pre-mature death. There are effective treatments that can be used to reduce fractures, including vitamin D, which is a low-cost, well-tolerated and easy treatment to deliver. Unfortunately our previous studies have shown that most LTC residents are not receiving effective fracture-prevention treatments. To determine our intervention's success, we will examine whether the rate of vitamin D use and other treatments increases, and whether fewer LTC residents fall and fracture. We are also interested in studying the strategy's format and feasibility and what future changes should be made.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: An Interdisciplinary Knowledge Translation Intervention in Long-term Care: The Vitamin D and Osteoporosis Study (ViDOS) Pilot Cluster Randomized Controlled Trial
Study Start Date : July 2009
Actual Primary Completion Date : February 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
No Intervention: LTC Osteoporosis Toolkit Only
Homes will receive the LTC osteoporosis toolkit only and will be required to attend an online webinar to outline the toolkit contents.
Active Comparator: Educ sessions & LTC Osteoporosis toolkit
LTC homes will receive the LTC osteoporosis toolkit, on line webinar. Three educational sessions lead by an osteoporosis expert will also take place, 1 on-site visit and 2 webinars.
Other: Educ sessions & LTC Osteoporosis toolkit
Three points of contact to be made. The first being a 1-hour personal visit at each intervention LTC home from an osteoporosis expert with the homes professional or health advisory committee (PAC or HAC). The second and third contact points will be made through webinars between the osteoporosis expert and the group from the first meeting.
Other Name: Knowledge translation

Primary Outcome Measures :
  1. Number of LTC residents on vitamin D [ Time Frame: 16 months ]

Secondary Outcome Measures :
  1. Number of falls and fractures [ Time Frame: 16 months ]
  2. Vitamin D dose [ Time Frame: 16 months ]
  3. Bisphosphonate use by LTC residents [ Time Frame: 16 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • LTC homes in Ontario that are serviced by MPGI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01398527

Canada, Ontario
McMaster University - St. Peter's Hospital
Hamilton, Ontario, Canada, L8M1W9
Sponsors and Collaborators
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Alexandra Papaioannou, MD, MSc McMaster University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Alexandra Papaioannou, Dr. Alexandra Papaioannou, McMaster University Identifier: NCT01398527     History of Changes
Other Study ID Numbers: REB 09-215
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: May 3, 2013
Last Verified: May 2013

Keywords provided by Alexandra Papaioannou, McMaster University:
Long-Term Care
Vitamin D

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents