Feasibility, Fidelity, and Acceptability of a Co-designed Intervention to Promote Mobility in Patients After Hip Fracture Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
This clinical study examines whether a co-designed mobility intervention can be delivered in routine hospital care after hip fracture surgery.
Hip fracture is a common and serious condition among older adults and is associated with loss of independence, complications, and increased mortality. During hospitalization, many patients remain inactive, even though early and frequent mobility is considered important for recovery.
The HIP-ME-UP intervention was developed in collaboration with healthcare professionals, patients, caregivers, and hospital management. It aims to support early mobilization, independence in basic mobility activities such as getting in and out of bed and increased physical activity during hospitalization.
The study will investigate whether the intervention is feasible to deliver in routine clinical practice, whether it is delivered as intended, and whether it is acceptable to patients and healthcare professionals.
Participants admitted after a hip fracture surgery will receive the intervention during hospitalization. Researchers will collect information on recruitment, retention, fidelity, acceptability, and mobility-related outcomes. Approximately 25 participants will be included.
The results will help determine whether a larger effectiveness study should be conducted.
详细描述
This study evaluates the feasibility, fidelity, and acceptability of a co-designed intervention developed within the HIP-ME-UP research program to promote early and frequent mobility among older adults hospitalized after hip fracture surgery.
Despite clinical recommendations for early mobilization, patients with hip fracture are often inactive during hospitalization, which may negatively impact recovery. The intervention was developed in collaboration with healthcare professionals, management, patients, and caregivers to address this gap.
The HIP-ME-UP intervention consists of four components:
- A dedicated porter supporting physiotherapy and occupational therapy mobility activities
- A standardized training concept to promote independence in getting in and out of bed
- Group-based exercise supervised by physiotherapists
- Personal activities of daily living (P-ADL) performed in the bathroom when feasible
The study uses a single-site, single-group feasibility design and will be conducted over an approximately 8-week period in orthopedic wards at Copenhagen University Hospital Hvidovre.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥ 60 years.
- •Admitted to one of the two acute orthopedic wards at Copenhagen University Hospital Hvidovre (CUHH) following hip fracture surgery.
- •Pre-fracture Cumulated Ambulation Score (CAS) (by recall) ≥ 3 points, indicating independence or assisted independence in basic mobility activities such as bed transfer, chair transfer, and indoor walking.
- •Participants may be included if they are able to provide informed consent independently or if informed consent is obtained from a legally authorized proxy (e.g., caregiver or close relative) in cases of cognitive impairment. This applies to both Danish- and non-Danish speaking patients. Non-Danish speakers may be included with support from translated study materials and assistance from relatives or interpreters, where appropriate.
- •Inclusion the latest on postoperative day three.
排除标准
- •Non-ambulatory before the fracture, e.g. permanently bedbound or wheelchair-dependent.
- •Terminal illness with limited expected survival.
- •Post-operative weight-bearing restrictions precluding mobility activities.
- •Multiple fractures or suspected pathological fractures (e.g. related to malignancy).
- •Clinically unstable or presenting conditions in which early mobilization is contraindicated.
- •Patients who previously participated in HIP-ME-UP Study 4, ensuring that recipients in Study 6 have not been prior HIP-ME-UP study participants or patient partners.
研究组 & 干预措施
HIP-ME-UP mobility intervention
Participants receive the HIP-ME-UP multicomponent mobility intervention during hospitalization after hip fracture surgery. The intervention aims to support early and frequent mobility through structured mobility support, supervised exercise, and encouragement of mobility-related daily activities.
干预措施: HIP-ME-UP mobility intervention (Behavioral)
结局指标
主要结局
Recruitment rate
时间窗: Continuous during recruitment period (up to 8 weeks)
Proportion of patients providing informed consent among those assessed for eligibility
Retention rate
时间窗: At discharge and 4 months post-discharge
Proportion of included participants completing planned assessments
Data completeness
时间窗: Through study completion, up to 4 months post-discharge
Proportion of completed data among expected assessments
Fidelity of intervention delivery
时间窗: Continuously targeted observations during the 8-week intervention period
Assessed via structured observations and logs reported as proportions and descriptive measures of adherence, dose, frequency, and quality
Patient acceptability of the intervention
时间窗: At discharge
Assessed using semi-structured interviews assessing perceived relevance, appropriateness, and burden of the intervention
Healthcare professional acceptability of the intervention
时间窗: The last four weeks of the intervention period or shortly thereafter
Assessed using semi-structured interviews and questionnaire responses based on the Theoretical Framework of Acceptability. All questionnaire items are scored on a 5-point Likert scale (1-5), higher scores depend on the item/domain, with higher scores indicating either greater acceptability for positively framed items or greater burden for negatively framed items
次要结局
未报告次要终点
研究者
Maria Swennergren Hansen
Principal Investigator
Copenhagen University Hospital, Hvidovre