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

Aging Clinical Trial

— MisterFIt  

Official title:

Multifaceted Intervention Using Telehealth to Reduce the Risk of Falls and Fractures in Older Men (MisterFit): A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05927623
• Other study ID #: MP-37-2022-8396
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2023
• Est. completion date: February 7, 2025

Study information

• Verified date: June 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Study Coordinator
• Phone: (514) 934-1934
• Email: michelle.wall[@]mail.mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 7, 2025
• Est. primary completion date: February 7, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Fractures, Bone
• Men
• Muscle Loss
• Osteoporosis
• Osteoporosis, Age-Related
• Osteoporotic Fractures

Intervention

Behavioral:
• Multifaceted Virtual Fracture Prevention Program
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.
• Attention Control
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

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	McMaster University	Hamilton	Ontario
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Centre Hospitalier Universitaire de Québec	Québec	Quebec
Canada	University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study recruitment rates (feasibility objective)	The study will be considered feasible if the investigators can recruit 12 participants per site within one year	12 months
Primary	Study retention rates (feasibility objective)	The study will be considered feasible if = 75 % of the sample completes the 12-month assessment	12 months
Primary	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.	12 months
Primary	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).	12 months
Secondary	Change of health-related quality of life	Measured using the multi-dimensional, self-administered EuroQol five-dimension (EQ-5D-3L) questionnaire	0, 6, and 12 months
Secondary	Change in social isolation	Measured using the UCLA 3-Item Loneliness Scale questionnaire	0, 6, and 12 months
Secondary	Change in the action planning phase of behaviour	Measured using the Health Action Process Approach (HAPA) questionnaire	6 and 12 months
Secondary	Change in self-efficacy, or confidence, for behaviors related to physical activity and calcium intake	Measured using the Osteoporosis Self-Efficacy Scale (OSES) questionnaire	0, 6, and 12 months
Secondary	Change in fear of falling in community-dwelling older adults	Measured using the seven-item self-administered Falls Efficacy Scale (FES) questionnaire	0, 6, and 12 months
Secondary	Change in physical activity	Measured using the Physical Activity Scale for the elderly (PASE) questionnaire	0, 6, and 12 months
Secondary	Change in total protein intake	Measured in grams using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool	2, 6, and 12 months
Secondary	Change in total calcium intake	Measured in mg using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool	2, 6, and 12 months
Secondary	Change in vitamin D intake	Measured in IU using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool	2, 6, and 12 months
Secondary	Changes in adherence to oral osteoporosis medications	Measured using the 8-item Osteoporosis-Specific Morisky Medication Adherence Scale (OS-MMAS)	2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months
Secondary	Change in functional leg muscle strength	Measured using the 30-second Chair stand test	0 and 12 months
Secondary	Change in gait speed	Measured using the 10-meter walk test	0 and 12 months
Secondary	Change in dynamic balance	Measured using the four-step square test	0 and 12 months
Secondary	Change in balance	Measured using the Short Form Berg Balance Scale (SF BBS-3P)	0 and 12 months
Secondary	Number of falls reported	Collected using falls calendar	2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months
Secondary	Healthcare utilization	Collected using healthcare utilization questionnaire	0, 6 and 12 months
Secondary	Reporting of safety outcomes (serious and non-serious adverse events)	Collected using Adverse Event Reporting	2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months