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临床试验/NCT06932224
NCT06932224进行中(未招募)不适用

Hospital-associated Deconditioning: Exploring Factors Contributing to the Physical and Cognitive Decline of Older Adults During Hospitalisation

University of Southampton1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年11月27日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
70
试验地点
1
主要终点
Muscle strength measured via a hand held dynamometer.

研究概览

简要总结

This study aims to investigate the impact of hospitalisation on physical and cognitive performance in patients aged 65 and older admitted with an orthopaedic injury. This will be achieved by asking patients to participate in a series of physical and cognitive performance questionnaires and tests. These questionnaires and tests will be performed by the patients as close to their admission as possible and then again at day 7 of hospitalisation (or discharge if earlier) and at 4-6 weeks after discharge. However, if a patient's hospital stay lasts more than 30 days, they will be asked to take part in the interim data collection timepoint.

To summarize, patients will be assessed at least 3 times, 4 if your hospital stay is longer than 30 days. The first and second assessments will be in the hospital, and the third will be 4-6 weeks after discharge at you home (or where is appropriate). Additionally, patients will be asked to wear an activity watch between the first and second assessment.

The study will also explore patients experiences of their hospital stay and opinions on deconditioning, including the views and opinions of hospital staff. This information will be gathered by having interviews with a sample of the patients who took part in the questionnaires and tests and by having interviews with hospital staff. The interview will be conducted by the main researcher, Thomas Cartledge, and will take place either over the phone, online or in-person, depending on your preference. The interviews will be audio and/or video recorded, however the recordings will be deleted immediately once transcription is completed. The duration of the interview will last approximately 30-60 mins.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient criteria:
  • •Older adults aged 65 years or older
  • •Able to provide written consent
  • •Admitted to Southampton General Hospital (SGH) for an acute orthopaedic condition
  • •Been admitted to SGH <72 hours before recruitment

排除标准

  • •Older adults who are not able to safely complete the quantitative measurement tools, as advised by the patient's clinician
  • •Patients receiving end of life care
  • •Require a hoist to transfer from bed to chair prior to hospitalisation
  • •Been admitted to SGH >72 hours before recruitment
  • •Unable to consent
  • •Hospital staff criteria:
  • •Work at SGH
  • •Work with older orthopaedic inpatients
  • •Be able to provide written consent

研究组 & 干预措施

Older patients with orthopaedic conditions/injuries

This cohort will take part in the physical and cognitive questionnaires and tests at all 3 (4 if interim is needed) time points.

20 patients of this cohort will take part in one semi-structured interview.

Southampton General Hospital Staff

10 hospital staff to take part in one semi-structured interview.

结局指标

主要结局

Muscle strength measured via a hand held dynamometer.

时间窗: From enrolment to the last data collection point at 4-6 weeks post discharge

Muscle mass measured via Bioelectrical Impedance Analysis.

时间窗: From enrolment to the last data collection point at 4-6 weeks post discharge.

The specific measure used will be fat free mass (FFM)

Sarcopenia risk assessed via the SARC-F questionnaire.

时间窗: From enrolment to the last data collection point at 4-6 weeks post discharge.

Strength, assistance with walking, rising from a chair, climbing stairs, and falls (SARC-F) questionnaire. Using a scale ranging from 0 to 10, with a higher score indicating a higher sarcopenia risk.

Functional mobility measured via the Short Physical Performance Battery (SPPB) questionnaire.

时间窗: 4-6 weeks (discharge to the final data collection point).

The SPPB score ranges from 0 to 12 points, with a higher score indicating better functional mobility.

Health-related quality of life measured by the EQ-5D questionnaire.

时间窗: From enrolment to the last data collection point at 4-6 weeks post discharge.

The EuroQol-5D (EQ-5D) is a two part questionnaire. The first part is a descriptive system using five dimensions to describe health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The second part is a visual analogue scale (VAS) where participants indicate their overall health by drawing a line on a scale from 100 (best imaginable health) to 0 (worst imaginable health).

Physical function measured via the Barthel Index questionnaire.

时间窗: From enrolment to the last data collection point at 4-6 weeks post discharge.

The original Barthel Index will be used, which uses a score ranging from 0 to 100. A higher score indicates a better physical function.

Cognitive impairment measured via The Montreal Cognitive Assessment (MoCA) score.

时间窗: From enrolment to the last data collection point at 4-6 weeks post discharge.

The MoCA score ranges from 0 to 30. A score of 26 or higher is generally considered normal, with lower scores indicating potential cognitive impairment.

Delirium measured via the 4AT score.

时间窗: From enrolment to the last data collection point at 4-6 weeks post discharge.

The 4AT test is scored from 0-12. A score of 0 suggests no delirium and no moderate-severe cognitive impairment. A score from 1-3 suggests cognitive impairment but not delirium. A score of 4 or more suggest delirium.

次要结局

  • Hospital re-admission rate(3 months)
  • Hospital re-admission rate(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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