Impact of an INtervention TO Increase MOBility in Older Hospitalized Medical Patients (INTOMOB): a Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 383
- 试验地点
- 8
- 主要终点
- Life-space level
研究概览
简要总结
Low mobility during an acute care hospitalization is very frequent, particularly among older patients, and associated with adverse outcomes, such as persistent functional decline, institutionalization and death. However, increasing hospital mobility remains challenging because of the multiple existing barriers.
The goal of this clinical trial is to test the effect of a multilevel intervention to increase hospital mobility, which addresses modifiable barriers and facilitators and does not require unavailable additional resources.
This study aims to answer whether this intervention can improve mobility and patient-relevant outcomes such as life-space mobility and functional status.
The multilevel intervention will target:
- The patients, who will receive an information booklet, a customizable diary, an exercise booklet and an iPad with access to the videos of the exercise booklet.
- The healthcare professionals (nursing staff and physicians) who will complete an e-learning, receive an oral presentation on the intervention, and receive a "mobility checklist" that reminds them of what they should assess daily regarding mobility.
- The hospital environment, where posters will be hung in the wards, including walking itineraries, on topics of interest to older adults.
In a first phase, the intervention will be pilot-tested in one ward of each hospital. The intervention will then be adapted based on patient and healthcare professional feedback.
In a second phase, the intervention will be tested in a cluster randomized controlled trial, and compared to standard of care.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Complete blinding is difficult due to the nature of the intervention and the design (cluster randomization).
To preserve blinding as much as possible, several strategies have been set.
At the cluster level (healthcare professional intervention): Since rotation across wards happens at the physician level, but is rare at the level of the nursing staff, the healthcare professional intervention targets mostly nurses. The healthcare professionals will be informed to avoid speaking about the intervention with colleagues of other wards.
At the patient level, differential information for candidates for the intervention or for the control group (the randomization group is known when first approaching candidates for participation because of the cluster design) will be provided. Candidates for the control group will receive only partial information without explaining the intervention. They will be informed orally at the end of the study about all aspects of the study.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Life-space level
时间窗: Day 30 (+/-5) after enrollment
Measured by the University of Alabama at Birmingham Study of Aging Life-Space Assessment (range 0-120, with maximum being a higher score = better outcome). For patients institutionalized, assessment through the Life-Space Assessment in Institutionalized Settings. Both scales can be merged since the scoring is similar. Assessment by telephone interview of the participant/relatives.
次要结局
- Depression(Day 180 (+/-5) after enrollment)
- Level of activity during hospitalization (hospitalization duration expected to be 3 to 20 days on average)(Discharge (hospitalization duration expected to be 3 to 20 days on average))
- Life-space level(Day 180 (+/-5) after enrollment)
- Activities of Daily Living(Day 180 (+/-5) after enrollment)
- Instrumental Activities of Daily Living(Day 180 (+/-5) after enrollment)
- Lower-limb muscle strength(Discharge (maximum 1 day before))
- Fall-risk increasing drugs(Day 180 (+/-5) after enrollment)
- Number of patients with fall(s) within 30 days after discharge(Day 30 (+/-5) after enrollment)
- Number of falls per patient within 30 days after discharge(Day 30 (+/-5) after enrollment)
- Number of patients with fall(s) within 180 days after discharge(Day 180 (+/-5) after enrollment)
- Number of patients with new institutionalization within 30 days of discharge(Day 30 (+/-5) after enrollment)
- Quality of life (EQ-5D)(Day 180 (+/-5) after enrollment)
- Pressure ulcer(Discharge (-1 to +2 days after discharge))
- Delirium during hospitalization (hospitalization duration expected to be 3 to 20 days on average)(Discharge (-1 to +2 days after discharge))
- Mobility at discharge(Discharge (maximum 1 day before))
- Step count during hospitalization (hospitalization duration expected to be 3 to 20 days on average)(Discharge (hospitalization duration expected to be 3 to 20 days on average))
- Number of patients with new institutionalization at discharge(Discharge (-1 to +2 days after discharge))
- Number of emergency room visits per patient within 180 days of discharge(Day 180 (+/-5) after enrollment)
- Hand-grip muscle strength(Discharge (maximum 1 day before))
- Fear of / concerns about falling(Day 180 (+/-5) after enrollment)
- Number of falls per patient within 180 days after discharge(Day 180 (+/-5) after enrollment)
- Number of patients with emergency room visits within 30 days of discharge(Day 30 (+/-5) after enrollment)
- Number of emergency room visits per patient within 30 days of discharge(Day 30 (+/-5) after enrollment)
- Number of patients with readmission within 30 days of discharge(Day 30 (+/-5) after enrollment)
- Number of readmissions per patient within 30 days of discharge(Day 30 (+/-5) after enrollment)
- Satisfaction with hospitalization(Discharge (-1 to +2 days after discharge))
- Perspectives on hospital mobility(Day 30 (+/-5) after enrollment)
- Location at follow-up(Day 180 (+/-5) after enrollment)
- Fall-risk increasing drugs during hospitalization(Discharge (discharge letter) (hospitalization duration expected to be 3 to 20 days on average)])
- Number of falls per patient during hospitalization (hospitalization duration expected to be 3 to 20 days on average)(Discharge (-1 to +2 days after discharge))
- Number of patients with new institutionalization within 180 days of discharge(Day 180 (+/-5) after enrollment)
- Number of patients with readmission within 180 days of discharge(Day 180 (+/-5) after enrollment)
- Number of patients with fall(s) during hospitalization (hospitalization duration expected to be 3 to 20 days on average)(Discharge (-1 to +2 days after discharge))
- Number of patients with emergency room visits within 180 days of discharge(Day 180 (+/-5) after enrollment)
- Number of readmissions per patient within 180 days of discharge(Day 180 (+/-5) after enrollment)
- Experience of the intervention(Discharge (-1 to +2 days after discharge))
- Discharge destination(Discharge (-1 to +2 days after discharge))