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A feasibility study investigating a programme to improve patient recovery following hip fracture through caregiver support

A feasibility study to assess the design of a multi-centre randomised controlled trial of the clinical and cost-effectiveness of a caregiving intervention for people following hip fracture surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13270387
Enrollment
132
Registered
2020-10-29
Start date
2021-04-12
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip fracture which is surgically managed Musculoskeletal Diseases Fracture of neck of femur, Fracture of hip

Interventions

Patient and caregiver dyads will be randomized to receive the intervention arm or control arm, using a secure online randomization service from the Norwich Clinical Trial Research Unit. Randomization
presence of patient cognitive impairment (AMTS score of either <8, or =8 points)
age (either <75, or =75 years)
whether the caregiver lives in the same house as the patient
and by whether the caregiver has been a caregiver previous to this hospital episode. Due to the participatory nature of rehabilitation, it will not be possible to blind patients, caregivers or treatin
education to patients and caregivers on recovery goal setting and expectations, pacing and stress management techniques for caregivers and patients and the provision of the HIP HELPER workbook providi

Sponsors

University of East Anglia
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients: 1. Community-dwelling 2. With or without cognitive impairment 3. Hip fracture which is operatively treated 4. Have an informal caregiver who is willing to provide support at home during recovery from surgery 5. A minimum of 10 patients with cognitive impairment, defined as Abbreviated Mental Test Score (AMTS) =8 points, will be recruited per group Patients' caregivers: 1. In the case of a patient with multiple caregivers, a single caregiver, nominated by the patient or consultee, ‘principal’ caregiver will be selected Embedded qualitative study: 1. Patient-caregiver dyads and physiotherapists, occupational therapists and nursing staff who deliver the HIP HELPER intervention who consent to participate in the qualitative study 2. Patient cognitive impairment in 30% of dyads includedin the qualitative study

Exclusion criteria

Exclusion criteria: 1. Acute, unstable, or terminal illness which would make participation in the rehabilitation strategies contraindicated and/or impractical 2. Expected by the clinical team to be discharged to a care home (residential or nursing) after their hospital admission 3. Principal (main) caregivers who have cognitive impairment (AMTS <8 points)

Design outcomes

Primary

MeasureTime frame
1. Ability to screen and identify potential participants (patients and caregivers) across the 4 sites measured using screening log data at baseline and 4 months follow-up 2. Willingness of eligible participants to consent and be randomised to intervention measured using semi-structured interviews at baseline and 4 months follow-up 3. Fidelity of healthcare professionals to deliver the experimental intervention and caregivers to adopt these post-discharge measured using semi-structured telephone interviews at baseline and 4 months follow-up 4. Risk of intervention contamination measured using semi-structured interviews at baseline and 4 months follow-up

Secondary

MeasureTime frame
1. Patients without cognitive impairment will be assessed for the following at baseline and 4 months follow-up: 1.1. Health resource use using the 5-level EuroQol 5-Dimension (EQ-5D-5L) health resource use questionnaire 1.2. Independence in activities of daily living using the Nottingham Activities of Daily Living Scale (NEADL) 1.3. Perceived self-efficacy using the General Self-Efficacy questionnaire 1.4. Depression symptoms using the Center for Epidemiologic Studies Depression Scale (CES-D) 1.5. Pain using the Numerical rating scale (NRS) for pain 1.6. Complications and adverse events including mortality using semi-structured interviews 2. All caregivers will be assessed for the following at baseline and 4 months follow-up: 2.1. Health resource use of patients using the 5-level EuroQol 5-Dimension (EQ-5D-5L) health resource use questionnaire 2.2. Depression symptoms of patients using the Center for Epidemiologic Studies Depression Scale (CES-D) 2.3. Caregiver burden using the Short Sense of Competence Questionnaire (SSCQ) 2.4. Health resource use and caregiver time use of patients, using the Resource Utilization in Dementia (RUD) questionnaire 2.5. Complications and adverse events of patients including mortality using semi-structured interviews 2.6. Patient and caregiver residential status using semi-structured interviews 3. Caregivers of patients with cognitive impairment will be assessed for the following at baseline and 4 months follow-up: 3.1. Functional ability of patients in activities of daily living using the Disability Assessment for Dementia Scale-6 (DADS-6) functional score 3.2. Neuropsychiatric symptoms of patients using the Neuropsychiatry Inventory (NPI) questionnaire 3.3. Pain of patients using the Abbey Pain Scale

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 8, 2026