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Vitamin D Osteoporosis Long-Term Care Study (ViDOS)

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Educ sessions & LTC Osteoporosis toolkit
Sponsored by
Canadian Institutes of Health Research (CIHR)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Osteoporosis focused on measuring Long-Term Care, Vitamin D

Eligibility Criteria

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

Inclusion Criteria:

  • LTC homes in Ontario that are serviced by MPGI

Sites / Locations

  • McMaster University - St. Peter's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

LTC Osteoporosis Toolkit Only

Educ sessions & LTC Osteoporosis toolkit

Arm Description

Homes will receive the LTC osteoporosis toolkit only and will be required to attend an online webinar to outline the toolkit contents.

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.

Outcomes

Primary Outcome Measures

Number of LTC residents on vitamin D

Secondary Outcome Measures

Number of falls and fractures
Vitamin D dose
Bisphosphonate use by LTC residents

Full Information

First Posted
July 19, 2011
Last Updated
May 2, 2013
Sponsor
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01398527
Brief Title
Vitamin D Osteoporosis Long-Term Care Study
Acronym
ViDOS
Official Title
An Interdisciplinary Knowledge Translation Intervention in Long-term Care: The Vitamin D and Osteoporosis Study (ViDOS) Pilot Cluster Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Long-Term Care, Vitamin D

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LTC Osteoporosis Toolkit Only
Arm Type
No Intervention
Arm Description
Homes will receive the LTC osteoporosis toolkit only and will be required to attend an online webinar to outline the toolkit contents.
Arm Title
Educ sessions & LTC Osteoporosis toolkit
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Educ sessions & LTC Osteoporosis toolkit
Other Intervention Name(s)
Knowledge translation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of LTC residents on vitamin D
Time Frame
16 months
Secondary Outcome Measure Information:
Title
Number of falls and fractures
Time Frame
16 months
Title
Vitamin D dose
Time Frame
16 months
Title
Bisphosphonate use by LTC residents
Time Frame
16 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: LTC homes in Ontario that are serviced by MPGI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Papaioannou, MD, MSc
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University - St. Peter's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M1W9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
32072073
Citation
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.
Results Reference
derived
PubMed Identifier
25962885
Citation
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.
Results Reference
derived
PubMed Identifier
24953541
Citation
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.
Results Reference
derived
PubMed Identifier
22624776
Citation
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.
Results Reference
derived

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Vitamin D Osteoporosis Long-Term Care Study

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