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Clinical Trials/ISRCTN13270387
ISRCTN13270387
Completed
未知

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

niversity of East Anglia0 sites114 target enrollmentOctober 29, 2020

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity of East Anglia
Enrollment
114
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34753296/ (added 04/08/2022) 2023 Interim results article in https://pubmed.ncbi.nlm.nih.gov/37977867/ Qualitative results from dyad interviews (added 20/11/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38070926/ (added 11/12/2023)

Registry
who.int
Start Date
October 29, 2020
End Date
September 30, 2022
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of East Anglia

Eligibility Criteria

Inclusion Criteria

  • 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

  • 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)

Outcomes

Primary Outcomes

Not specified

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