Multifaceted Intervention Using Telehealth to Reduce the Risk of Falls and Fractures in Older Men (MisterFit): A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 5
- 主要终点
- Adherence to the exercise and nutrition interventions (feasibility objective)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Physical measures including balance, muscle strength, and gait speed will be recorded by an outcome assessor blind to group assignment.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Misterfit online group
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.
干预措施: Multifaceted Virtual Fracture Prevention Program (Behavioral)
MisterFit offline group
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.
干预措施: Attention Control (Behavioral)
结局指标
主要结局
Adherence to the exercise and nutrition interventions (feasibility objective)
时间窗: 12 months
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)
时间窗: 12 months
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).
Study recruitment rates (feasibility objective)
时间窗: 12 months
The study will be considered feasible if the investigators can recruit 12 participants per site within one year
Study retention rates (feasibility objective)
时间窗: 12 months
The study will be considered feasible if ≥ 75 % of the sample completes the 12-month assessment
次要结局
- Change in gait speed(0 and 12 months)
- Change of health-related quality of life(0, 6, and 12 months)
- Change in social isolation(0, 6, and 12 months)
- Change in the action planning phase of behaviour(6 and 12 months)
- Change in self-efficacy, or confidence, for behaviors related to physical activity and calcium intake(0, 6, and 12 months)
- Change in fear of falling in community-dwelling older adults(0, 6, and 12 months)
- Change in physical activity(0, 6, and 12 months)
- Change in total protein intake(2, 6, and 12 months)
- Change in total calcium intake(2, 6, and 12 months)
- Change in vitamin D intake(2, 6, and 12 months)
- Change in functional leg muscle strength(0 and 12 months)
- Change in dynamic balance(0 and 12 months)
- Change in balance(0 and 12 months)
- Number of falls reported(2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months)
- Healthcare utilization(0, 6 and 12 months)
- Reporting of safety outcomes (serious and non-serious adverse events)(2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months)
研究者
Suzanne Morin
Dr.
McGill University Health Centre/Research Institute of the McGill University Health Centre