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CompletedNCT01398527ViDOSUpdated Jul 1, 2025

Vitamin D Osteoporosis Long-Term Care Study

An interventional study of Educ sessions & LTC Osteoporosis toolkit in Osteoporosis, sponsored by McMaster University. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2025-07-01.

Sponsored by McMaster University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Osteoporosis

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Keywords

  • Long-Term Care
  • Vitamin D
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 40 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • LTC homes in Ontario that are serviced by MPGI
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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.

Interventions

  • OtherEduc 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.

    Also known as: Knowledge translation

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What researchers measure

Primary outcomes

  1. Number of LTC residents on vitamin D

    Time frame: 16 months

Secondary outcomes

  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

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Study locations

1 site
  • McMaster University - St. Peter's Hospital
    Hamilton, Ontario L8M1W9, Canada
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References and documents

Publications

  • Borhan S, Kennedy C, Ioannidis G, Papaioannou A, Adachi J, Thabane L. An empirical comparison of methods for analyzing over-dispersed zero-inflated count data from stratified cluster randomized trials. Contemp Clin Trials Commun. 2020 Feb 1;17:100539. doi: 10.1016/j.conctc.2020.100539. eCollection 2020 Mar. PubMed 32072073 ↗
  • Kennedy CC, Ioannidis G, Thabane L, Adachi JD, Marr S, Giangregorio LM, Morin SN, Crilly RG, Josse RG, Lohfeld L, Pickard LE, van der Horst ML, Campbell G, Stroud J, Dolovich L, Sawka AM, Jain R, Nash L, Papaioannou A. Successful knowledge translation intervention in long-term care: final results from the vitamin D and osteoporosis study (ViDOS) pilot cluster randomized controlled trial. Trials. 2015 May 12;16:214. doi: 10.1186/s13063-015-0720-3. PubMed 25962885 ↗
  • Kennedy CC, Thabane L, Ioannidis G, Adachi JD, Papaioannou A; ViDOS Investigators. Implementing a knowledge translation intervention in long-term care: feasibility results from the Vitamin D and Osteoporosis Study (ViDOS). J Am Med Dir Assoc. 2014 Dec;15(12):943-5. doi: 10.1016/j.jamda.2014.05.007. Epub 2014 Jun 18. PubMed 24953541 ↗
  • Kennedy CC, Ioannidis G, Giangregorio LM, Adachi JD, Thabane L, Morin SN, Crilly RG, Marr S, Josse RG, Lohfeld L, Pickard LE, King S, van der Horst ML, Campbell G, Stroud J, Dolovich L, Sawka AM, Jain R, Nash L, Papaioannou A. An interdisciplinary knowledge translation intervention in long-term care: study protocol for the vitamin D and osteoporosis study (ViDOS) pilot cluster randomized controlled trial. Implement Sci. 2012 May 24;7:48. doi: 10.1186/1748-5908-7-48. PubMed 22624776 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01398527
Lead sponsor
McMaster University
Responsible party
Alexandra Papaioannou (Dr. Alexandra Papaioannou, McMaster University) — Principal investigator
First posted
Jul 20, 2011
Start date
Jul 2009
Primary completion
Feb 2013
Completion
May 2013
Last update
Jul 1, 2025

Study contacts

Alexandra Papaioannou, MD, MSc
principal investigator · McMaster University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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