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Multifaceted Intervention Using Telehealth to Reduce the Risk of Falls and Fractures in Older Men (MisterFIt)

Primary Purpose

Osteoporosis, Osteoporotic Fractures, Osteoporosis, Age-Related

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Multifaceted Virtual Fracture Prevention Program
Attention Control
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Community-dwelling individuals ≥ 60 years who self-identify as men will be considered eligible if their risk for fracture is evaluated to be high, defined by the presence of one of the following inclusion criteria: Individuals on a Heath Canada-approved anti-osteoporosis medication (oral or intravenous bisphosphonate, denosumab, teriparatide, or romozosumab) to reduce fracture risk Prior hip or clinically diagnosed vertebral fracture or prior multiple fragility fractures since age 40 Fracture at any skeletal site (excluding skull, hands, and feet) within the previous 2 years Ten-year probability of major osteoporotic fracture of ≥20% using the FRAX tool BMD T-score of ≤ -2.0 (performed as part of usual clinical care) WITH either the presence of one or more moderate or severe vertebral fractures on spine radiography OR the presence of ≥1 comorbidities (Diabetes Type I or Type II if on treatment, Parkinson's disease, congestive heart failure, chronic obstructive pulmonary disease (COPD) with previous systemic corticosteroid exposure, prostate cancer with current or prior recent (≤ 2 years) use of hormonal therapy) OR ≥ 2 falls in the previous year. Exclusion Criteria: Inability to communicate in English or French; No access to a mobile device, tablet, or computer with a camera; Clinical or symptomatic spine fracture in the last 4 months, or a lower/upper limb fracture in the last 2 months; Uncontrolled medical comorbidity including but not limited to congestive heart failure exacerbation in the last 12 months or COPD exacerbation in the last 3 months Currently doing similar exercise program ≥ 2x/week Unable to perform basic activities of daily living or severe cognitive impairment or terminal illness Presence of absolute exercise contraindications unless physician approval is obtained if contraindications are present

Sites / Locations

  • University of Calgary
  • McMaster University
  • University Health Network
  • McGill University Health CentreRecruiting
  • Centre Hospitalier Universitaire de Québec

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Misterfit online group

MisterFit offline group

Arm Description

The Misterfit online group will receive a 12-month virtually-delivered fracture prevention intervention that includes a personalized gender-tailored strength training and balance-based exercise program, nutritional counselling and fall and fracture prevention education.

The Misterfit offline group will act as an attention control group receiving a fracture prevention intervention with the same components as the experimental group, but the components will not be virtual, personalized or gender-tailored.

Outcomes

Primary Outcome Measures

Study recruitment rates (feasibility objective)
The study will be considered feasible if the investigators can recruit 12 participants per site within one year
Study retention rates (feasibility objective)
The study will be considered feasible if ≥ 75 % of the sample completes the 12-month assessment
Adherence to the exercise and nutrition interventions (feasibility objective)
The exercise intervention will be considered feasible if participants complete ≥ 65% of the prescribed number of exercise sessions at the 12-month follow-up. The nutrition intervention will be considered feasible if participants attend 66% of the visits.
Perceived usability and satisfaction of the telehealth platform application (feasibility objective)
Measured using the the System Usability Scale (SUS) where scores range from 0 (very poor) to 100 (excellent). Usability will be deemed to be acceptable if the mean SUS score is above 68 (SUS ≥ 68 = average user experience).

Secondary Outcome Measures

Change of health-related quality of life
Measured using the multi-dimensional, self-administered EuroQol five-dimension (EQ-5D-3L) questionnaire
Change in social isolation
Measured using the UCLA 3-Item Loneliness Scale questionnaire
Change in the action planning phase of behaviour
Measured using the Health Action Process Approach (HAPA) questionnaire
Change in self-efficacy, or confidence, for behaviors related to physical activity and calcium intake
Measured using the Osteoporosis Self-Efficacy Scale (OSES) questionnaire
Change in fear of falling in community-dwelling older adults
Measured using the seven-item self-administered Falls Efficacy Scale (FES) questionnaire
Change in physical activity
Measured using the Physical Activity Scale for the elderly (PASE) questionnaire
Change in total protein intake
Measured in grams using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
Change in total calcium intake
Measured in mg using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
Change in vitamin D intake
Measured in IU using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
Changes in adherence to oral osteoporosis medications
Measured using the 8-item Osteoporosis-Specific Morisky Medication Adherence Scale (OS-MMAS)
Change in functional leg muscle strength
Measured using the 30-second Chair stand test
Change in gait speed
Measured using the 10-meter walk test
Change in dynamic balance
Measured using the four-step square test
Change in balance
Measured using the Short Form Berg Balance Scale (SF BBS-3P)
Number of falls reported
Collected using falls calendar
Healthcare utilization
Collected using healthcare utilization questionnaire
Reporting of safety outcomes (serious and non-serious adverse events)
Collected using Adverse Event Reporting

Full Information

First Posted
June 21, 2023
Last Updated
June 28, 2023
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT05927623
Brief Title
Multifaceted Intervention Using Telehealth to Reduce the Risk of Falls and Fractures in Older Men
Acronym
MisterFIt
Official Title
Multifaceted Intervention Using Telehealth to Reduce the Risk of Falls and Fractures in Older Men (MisterFit): A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2023 (Actual)
Primary Completion Date
February 7, 2025 (Anticipated)
Study Completion Date
February 7, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Men sustain over one-third of osteoporosis-related fractures worldwide. The burden of osteoporotic fractures in older men is substantial, and men suffer significantly worse fracture-related outcomes than women. Following a fracture, men sustain greater rates of subsequent fractures, loss of autonomy, and mortality than women and the imminent risk of re-fracture is several times higher in men than in women. Functional mobility, known to predict falls and fractures, is also notably worse in men following a fracture. In the fiscal year 2007-08, the overall annual costs of osteoporosis in Canadian men was evaluated to be $910 million. Osteoporosis is primarily considered a disease of older women, and men are remarkably under-evaluated and under-treated for it. Recognition of sex and gender influences on skeletal health in men has been very slow; akin to the gap in cardiovascular diseases, where women are far less likely to receive guideline-recommended investigations and treatment. Over 85% of Canadian men who suffer from fragility fractures do not receive osteoporosis screening and/or treatment strategies. The existence of this care gap in men underscores our current struggle to overcome important barriers including: 1) men's lack of awareness of the critical impact of osteoporosis and fractures on several aspects of their lives, and of the benefits of treatment; and 2) the absence of comprehensive and accessible treatments tailored to men. Informed by the Knowledge-to-Action framework, we aim to address these barriers by adapting interventions with proven efficacy to engage men at high fracture risk in health behaviour change. The current protocol is for a pilot RCT to determine the feasibility of recruitment and retention, adherence to, and acceptability of the virtually-delivered fracture prevention intervention only. Our long-term goal is to conduct a large pragmatic randomized controlled trial (RCT) to address the research question: In older adults at high risk for fractures who self-identify as men, does anti-osteoporosis pharmacotherapy in conjunction with a virtually-delivered intervention that includes a gender-tailored strength training and balance based exercise program and nutritional counselling, improve functional mobility compared to anti-osteoporosis pharmacotherapy in conjunction with an attention control intervention.
Detailed Description
The current proposal for this assessor-blind parallel group multicenter pilot RCT of 12 months duration is in line with published frameworks for pilot studies in preparation for RCTs. For the pilot study, the investigators will enroll participants irrespective of anti-osteoporosis medication use. This pilot RCT will determine the following primary feasibility objectives which will be assessed at 12 months : Study recruitment rates: The study will be considered feasible if the investigators can recruit 12 participants per site within one year. Recruitment of 12 participants/site/year will translate to 360 participants with 10 sites over 3 years, which is the estimated sample size required for our future RCT with primary outcomes of physical function and fall rates, and secondary outcomes of bone strength. Study retention rates: The study will be considered feasible if ≥ 75 % of the sample completes the 12-month assessment. This estimation is based on exercise RCTs where the attrition rate at 12 months ranged between 4% to 13% in community-based healthy men and up to 17% in frail older men. Adherence to the exercise and nutrition interventions: The exercise intervention will be considered feasible if participants complete ≥ 65% of the prescribed number of exercise sessions at the 12-month follow-up. Beneficial effects of in-person supervised exercise on physical function in older men and women have been shown with a mean exercise session adherence of 60% at 12 months, and with a mean exercise session adherence of 63% in older men at 18 months. The nutrition intervention will be considered feasible if participants attend 66% of the visits. Perceived usability of the telehealth platform application: via the System Usability Scale (SUS) where scores range from 0 (very poor) to 100 (excellent). Usability will be deemed to be acceptable if the mean SUS score is above 68 (SUS ≥ 68 = average user experience). The investigators will also report exploratory analyses comparing the effect of the virtual intervention group to an attention control group. Exploratory outcomes will include the number of falls and fractures, changes in physical function (measured by lower extremity strength, gait speed, and balance), fall self-efficacy, quality of life and self-management behaviors in nutrition and exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Osteoporotic Fractures, Osteoporosis, Age-Related, Muscle Loss, Men, Aging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Assessor-blind parallel group multicenter pilot RCT of 12 months duration.
Masking
Outcomes Assessor
Masking Description
Physical measures including balance, muscle strength, and gait speed will be recorded by an outcome assessor blind to group assignment.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Misterfit online group
Arm Type
Experimental
Arm Description
The Misterfit online group will receive a 12-month virtually-delivered fracture prevention intervention that includes a personalized gender-tailored strength training and balance-based exercise program, nutritional counselling and fall and fracture prevention education.
Arm Title
MisterFit offline group
Arm Type
Other
Arm Description
The Misterfit offline group will act as an attention control group receiving a fracture prevention intervention with the same components as the experimental group, but the components will not be virtual, personalized or gender-tailored.
Intervention Type
Behavioral
Intervention Name(s)
Multifaceted Virtual Fracture Prevention Program
Intervention Description
Personalized exercise prescription: Comprised of muscle strengthening and balance exercises to perform three times a week, delivered and monitored remotely via the MisterFit app, a branded version of the secure commercially available Physiotec app (physiotec.com) and monthly virtual exercise consultations. Virtual nutrition counseling from a registered dietitian in months 2, 4 and 6: to encourage participants to meet daily targets for calcium and vitamin D (preferably from diet), and protein intake to support muscle accretion and target weight maintenance Virtual interactive information sessions in month 4 and 8: to education participants on topics identified as important by the Misterfit patient partner advisory committee.
Intervention Type
Behavioral
Intervention Name(s)
Attention Control
Intervention Description
Encouraged to meet the 24-Hour Movement Guidelines for adults aged 65 years or older (https://csepguidelines.ca) with telephone contacts at the same frequency that the Misterfit online group receives virtual exercise consultations Nutritional fact sheets: sent by e-mail at the same frequency that the Misterfit online group meets with the research dietitian. Educational fact sheets: sent by e-mail at the same frequency that the Misterfit Online group has virtual interactive information sessions
Primary Outcome Measure Information:
Title
Study recruitment rates (feasibility objective)
Description
The study will be considered feasible if the investigators can recruit 12 participants per site within one year
Time Frame
12 months
Title
Study retention rates (feasibility objective)
Description
The study will be considered feasible if ≥ 75 % of the sample completes the 12-month assessment
Time Frame
12 months
Title
Adherence to the exercise and nutrition interventions (feasibility objective)
Description
The exercise intervention will be considered feasible if participants complete ≥ 65% of the prescribed number of exercise sessions at the 12-month follow-up. The nutrition intervention will be considered feasible if participants attend 66% of the visits.
Time Frame
12 months
Title
Perceived usability and satisfaction of the telehealth platform application (feasibility objective)
Description
Measured using the the System Usability Scale (SUS) where scores range from 0 (very poor) to 100 (excellent). Usability will be deemed to be acceptable if the mean SUS score is above 68 (SUS ≥ 68 = average user experience).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change of health-related quality of life
Description
Measured using the multi-dimensional, self-administered EuroQol five-dimension (EQ-5D-3L) questionnaire
Time Frame
0, 6, and 12 months
Title
Change in social isolation
Description
Measured using the UCLA 3-Item Loneliness Scale questionnaire
Time Frame
0, 6, and 12 months
Title
Change in the action planning phase of behaviour
Description
Measured using the Health Action Process Approach (HAPA) questionnaire
Time Frame
6 and 12 months
Title
Change in self-efficacy, or confidence, for behaviors related to physical activity and calcium intake
Description
Measured using the Osteoporosis Self-Efficacy Scale (OSES) questionnaire
Time Frame
0, 6, and 12 months
Title
Change in fear of falling in community-dwelling older adults
Description
Measured using the seven-item self-administered Falls Efficacy Scale (FES) questionnaire
Time Frame
0, 6, and 12 months
Title
Change in physical activity
Description
Measured using the Physical Activity Scale for the elderly (PASE) questionnaire
Time Frame
0, 6, and 12 months
Title
Change in total protein intake
Description
Measured in grams using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
Time Frame
2, 6, and 12 months
Title
Change in total calcium intake
Description
Measured in mg using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
Time Frame
2, 6, and 12 months
Title
Change in vitamin D intake
Description
Measured in IU using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
Time Frame
2, 6, and 12 months
Title
Changes in adherence to oral osteoporosis medications
Description
Measured using the 8-item Osteoporosis-Specific Morisky Medication Adherence Scale (OS-MMAS)
Time Frame
2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months
Title
Change in functional leg muscle strength
Description
Measured using the 30-second Chair stand test
Time Frame
0 and 12 months
Title
Change in gait speed
Description
Measured using the 10-meter walk test
Time Frame
0 and 12 months
Title
Change in dynamic balance
Description
Measured using the four-step square test
Time Frame
0 and 12 months
Title
Change in balance
Description
Measured using the Short Form Berg Balance Scale (SF BBS-3P)
Time Frame
0 and 12 months
Title
Number of falls reported
Description
Collected using falls calendar
Time Frame
2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months
Title
Healthcare utilization
Description
Collected using healthcare utilization questionnaire
Time Frame
0, 6 and 12 months
Title
Reporting of safety outcomes (serious and non-serious adverse events)
Description
Collected using Adverse Event Reporting
Time Frame
2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Community-dwelling individuals ≥ 60 years who self-identify as men
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Community-dwelling individuals ≥ 60 years who self-identify as men will be considered eligible if their risk for fracture is evaluated to be high, defined by the presence of one of the following inclusion criteria: Individuals on a Heath Canada-approved anti-osteoporosis medication (oral or intravenous bisphosphonate, denosumab, teriparatide, or romozosumab) to reduce fracture risk Prior hip or clinically diagnosed vertebral fracture or prior multiple fragility fractures since age 40 Fracture at any skeletal site (excluding skull, hands, and feet) within the previous 2 years Ten-year probability of major osteoporotic fracture of ≥20% using the FRAX tool BMD T-score of ≤ -2.0 (performed as part of usual clinical care) WITH either the presence of one or more moderate or severe vertebral fractures on spine radiography OR the presence of ≥1 comorbidities (Diabetes Type I or Type II if on treatment, Parkinson's disease, congestive heart failure, chronic obstructive pulmonary disease (COPD) with previous systemic corticosteroid exposure, prostate cancer with current or prior recent (≤ 2 years) use of hormonal therapy) OR ≥ 2 falls in the previous year. Exclusion Criteria: Inability to communicate in English or French; No access to a mobile device, tablet, or computer with a camera; Clinical or symptomatic spine fracture in the last 4 months, or a lower/upper limb fracture in the last 2 months; Uncontrolled medical comorbidity including but not limited to congestive heart failure exacerbation in the last 12 months or COPD exacerbation in the last 3 months Currently doing similar exercise program ≥ 2x/week Unable to perform basic activities of daily living or severe cognitive impairment or terminal illness Presence of absolute exercise contraindications unless physician approval is obtained if contraindications are present
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
(514) 934-1934
Ext
45742
Email
michelle.wall@mail.mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Morin, MD
Organizational Affiliation
Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charley Hasselaar
Email
cmhassel@ucalgary.ca
First Name & Middle Initial & Last Name & Degree
Emma Billington, MD
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolyn Leckie
Email
leckiece@gmail.com
First Name & Middle Initial & Last Name & Degree
Alexandra Papaioannou, MD, MSc
First Name & Middle Initial & Last Name & Degree
Jonathan Adachi, MD
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasmine Lakhesar, MD, PhD
Email
Jasmine.Lakhesar@uhn.ca
First Name & Middle Initial & Last Name & Degree
Angel Cheung, MD, PhD
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khiran Arumugam
Phone
(514) 934-1934
Ext
47071
Email
khiran.arumugam@mail.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Suzanne Morin, MD
Facility Name
Centre Hospitalier Universitaire de Québec
City
Québec
State/Province
Quebec
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Chouinard-Castonguay
Email
Sarah.Chouinard-Castonguay@crchudequebec.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Claudia Gagnon, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Multifaceted Intervention Using Telehealth to Reduce the Risk of Falls and Fractures in Older Men

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