Comparing Two Ways to Reduce Future Fall Injuries Among Older Adults Who Have Fallen - The WISE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,139
- 试验地点
- 2
- 主要终点
- Number of Participants Experiencing Fragility Fractures and Serious Fall-Related Injuries (FF/SFI)
研究概览
简要总结
The investigators propose a 36-month multi-center randomized effectiveness trial to compare the impact of an Enhanced Usual Care (Control) intervention, with Exercise Coaching (Exercise), on Serious Fall-Related Injuries (SFI) in patients with a previous fragility fracture (FF).
The investigators will also examine the impact of the intervention on several secondary outcomes like: loneliness, physical function, and bone strength. The investigators will do this by following a Pragmatic trial design: 1) limiting exclusions to increase representativeness, 2) limiting research contacts (average 30 min/year) and 3) limiting measures to those practicable for use in usual care.
详细描述
The intervention will be held in churches, community centers, and senior residential facilities. Investigators will work with the exercise sites to recruit up to 125 individuals (5 per exercise site location) to serve as the Group leaders at each site location. Group leaders will be trained on the exercises and leadership roles to help lead the group. The investigators will ask them to come at least once per week, so the time commitment is minimal.
The investigators will be recruiting 1130 patients who have suffered a fragility fracture and will randomly assign them to one of two conditions: (A) Control Group - Enhanced Usual Care and (B) Intervention Group - Enhanced usual care plus Exercise coaching that includes in-person and phone coach contacts to encourage and support strength, balance and walking activities.
*Due to the COVID-19 pandemic, the in-person intervention was stopped in March, 2020 and a Zoom-based virtual intervention was introduced in April, 2020. Participants that join the Zoom-based virtual intervention are led by staffed exercise coaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 65 years old
- •Previous Fragility Fracture (FF) in past 10 years.
- •Able to speak and understand English.
- •Participants will need to be willing to try exercising and agree to annual follow-up measurements.
排除标准
- •If the answer to the following questions are "yes", the investigators will exclude the participant from the study Do you feel pain in your chest, neck, jaw, or arms at rest, during your daily activities of living, OR when you do physical activity? Have you ever been told by a health professional that you should not exercise OR exercise only when supervised by a professional?
- •If the answer to the following questions are "yes", the investigators will contact physician for permission Do you experience unpleasant awareness of a forceful or rapid heart rate? Do you experience unreasonable breathlessness? Do you experience dizziness fainting or blackouts? Do you experience ankle swelling? Do you have burning or cramping sensation on your lower legs when walking short distances? Do you have diabetes?
- •Has a doctor, nurse or health professional ever told you that you had any of the following? Weak or failing kidneys? A heart attack, also called a myocardial infarction? Angina or coronary heart disease? A stroke? Any kind of heart condition or heart disease other than the ones I just asked about?
- •Unable to obtain primary care provider consent (if required based on questions above)
- •If the participant answer "NO" to the following question: Is it ok if the investigators contact your primary care provider?
- •If the participant answer "YES" to the following question:Have you been hospitalized for psychiatric problem in past year?
- •If the participant is planning on moving out of the area in the next 36 months
- •If currently participates in the Band Together exercise program
- •Positive Callahan cognition screener: If participant fails 2 questions, research coordinator will explain study in detail and ask read-back questions. The participant will be excluded if failed read-back.
研究组 & 干预措施
Enhanced Usual Care - control group
Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure.
Enhanced Usual Care plus Exercise Coaching Intervention
Participants will receive the three printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) rregular progress reports sent by coaches to primary care providers via fax/electronic health records every 6 months, to communicate the patient's progress.
干预措施: Enhanced Usual Care plus Exercise Coaching (Behavioral)
结局指标
主要结局
Number of Participants Experiencing Fragility Fractures and Serious Fall-Related Injuries (FF/SFI)
时间窗: 36 months
Every 4 months the investigators will call the participants asking questions about the main outcome, FF/SFI. A fall calendar will be given to the participant to record all fall events (e.g., date, location). This will help participants to recall falls during the 4 month period. In addition, this will allow medical records to be requested, using a signed authorization form (part of the consent form). The investigators will review all relevant Electronic Health Records (EHR) information, such as hospital and emergency department discharge summaries, outpatient visit notes, consultation notes, physical exam notes, dictated radiologist notes and plain film radiography.
次要结局
- Number of Falls and Falls-related Injuries Using the Behavioral Risk Factor Surveillance System (BRFSS)(36 months)
- Percentage of Participants With Excellent/Very Good Health Using the Patient Reported Outcomes Measurement Information System (PROMIS)(36 months)
- Assessment of Fear of Falling Using the Falls Efficacy Scale International (FES-I)(36 months)
- Assessment of Physical Function Using PROMIS(36 months)
- Assessment of Depression Using PROMIS(36 months)
- Assessment of Anxiety Using PROMIS(36 months)
- Assessment of Loneliness Using PROMIS(36 months)
- Percentage of Participants Meeting Physical Activity Guidelines Using the National Health Interview Survey (NHIS)(36 months)
研究者
Christopher Sciamanna, MD, MPH
Prof. Medicine and Public Health Sciences, Division Chief Population Health Research and Development
Milton S. Hershey Medical Center