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Clinical Trials/ISRCTN69957256
ISRCTN69957256
Completed
未知

Prevention and rehabilitation of osteoporotic fractures In disadvantaged populations 2 – subproject 3: a multifactorial intervention for osteoporotic fracture patients with incipient to moderate cognitive impairment and their caregivers: a dual-center randomized controlled trial

Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF), executive center: Robert Bosch Hospital0 sites240 target enrollmentJuly 28, 2015

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF), executive center: Robert Bosch Hospital
Enrollment
240
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

2019 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/31039754 (added 02/05/2019)

Registry
who.int
Start Date
July 28, 2015
End Date
September 17, 2018
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF), executive center: Robert Bosch Hospital

Eligibility Criteria

Inclusion Criteria

  • Inclusion criteria patients:
  • 1\. Hip or pelvic fracture if not older than 3 months
  • 2\. Community\-dwelling
  • 3\. 4 m independent walking with walking aid
  • 4\. Age: 65 years and older
  • 5\. Cognitive impairment defined by having a Mini\-Mental State Examination (MMSE) score of 17\-26
  • 6\. Visual acuity: Snellen fraction \=20/400
  • Inclusion criteria caregivers:
  • 1\. Supports patient \= 10\.5 hours per week (informal care in ADL, IADL, and supervision)
  • 2\. The support is not commercial

Exclusion Criteria

  • Exclusion criteria patients:
  • 1\. Delirium,
  • 2\. Severe somatic or mental disease, which doesn’t allow participation,
  • 3\. Patient is not able to understand and speak German,
  • 4\. No telephone available
  • 5\. Place of domicile not reachable by public transport in the region of the study center Stuttgart or \>50 km away from the study center Heidelberg,
  • 6\. Assessment T1b cannot be conducted at the person´s home in week 1\-6 after rehabilitation,
  • 7\. Moderate to severe aphasia (amnestic aphasia is not an exclusion criteria) or severe apraxia of speech, 8\. Progressive, terminal status,
  • 9\. Insufficient hearing ability to conduct phone calls
  • Exclusion criteria caregivers:

Outcomes

Primary Outcomes

Not specified

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