Clinical trial NCT05927623: Multifaceted Intervention Using Telehealth to Reduce the Risk of Falls and Fractures in Older Men
Official title: Multifaceted Intervention Using Telehealth to Reduce the Risk of Falls and Fractures in Older Men (MisterFit): A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoporosis
Osteoporotic Fractures
Osteoporosis, Age-Related
Muscle Loss
Men
Aging
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-07-03
Enrollment: 60
Sex: MALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assessor-blind parallel group multicenter pilot RCT of 12 months duration.
Primary purpose: TREATMENT

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 :

1. 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.
2. 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.
3. 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.
4. 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.

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
* BMD T-score of ≤ -2.5 and ≥ 70 years of age

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 or planning to start doing either: A) Resistance training exercises with a self-rated intensity of very hard (e.g., rated ≥ 8 on a scale from 0-10) for two or more times a week OR B) Exercises to improve balance for two or more times a 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

Primary outcomes:
measure: Study recruitment rates (feasibility objective)
timeFrame: 12 months
measure: Study retention rates (feasibility objective)
timeFrame: 12 months
measure: Adherence to the exercise and nutrition interventions (feasibility objective)
timeFrame: 12 months
measure: Perceived usability and satisfaction of the telehealth platform application (feasibility objective)
timeFrame: 12 months
Secondary outcomes:
measure: Change of health-related quality of life
timeFrame: 0, 6, and 12 months
measure: Change in social isolation
timeFrame: 0, 6, and 12 months
measure: Change in the action planning phase of behaviour
timeFrame: 6 and 12 months
measure: Change in self-efficacy, or confidence, for behaviors related to physical activity and calcium intake
timeFrame: 0, 6, and 12 months
measure: Change in fear of falling in community-dwelling older adults
timeFrame: 0, 6, and 12 months
measure: Change in physical activity
timeFrame: 0, 6, and 12 months
measure: Change in total protein intake
timeFrame: 2, 6, and 12 months
measure: Change in total calcium intake
timeFrame: 2, 6, and 12 months
measure: Change in vitamin D intake
timeFrame: 2, 6, and 12 months
measure: Change in functional leg muscle strength
timeFrame: 0 and 12 months
measure: Change in gait speed
timeFrame: 0 and 12 months
measure: Change in dynamic balance
timeFrame: 0 and 12 months
measure: Change in balance
timeFrame: 0 and 12 months
measure: Number of falls reported
timeFrame: 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months
measure: Healthcare utilization
timeFrame: 0, 6 and 12 months
measure: Reporting of safety outcomes (serious and non-serious adverse events)
timeFrame: 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Québec
country: Canada
facility: Centre Hospitalier Universitaire de Québec
state: Quebec
Study officials:
affiliation: Research Institute of the McGill University Health Centre
name: Suzanne Morin, MD
role: PRINCIPAL_INVESTIGATOR
References: