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 - PROFinD 2

Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)0 sites240 target enrollmentJuly 17, 2015

Overview

Phase: 未知
Intervention: Not specified
Conditions: Hip / pelvic fractureIncipient- to moderate-stage cognitive impairment (Score Mini Mental State Examination: 17-26)
Sponsor: Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
Enrollment: 240
Status: Completed
Last Updated: last year

No summary available.

Registry

who.int

Start Date

July 17, 2015

End Date

September 17, 2018

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

•Inclusion criteria patients: (1\) hip or pelvic fracture during the last 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, (3\) \= 18 years of age, (4\) willing to attend a personal consultation at the patient's home

•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 T1 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: (1\) current mental illness or cognitive impairment that affects the ability to understand the requirements of the assessments, to participate in the intervention or to give informed consent, (2\) no telephone available, (3\) insufficient hearing ability to conduct phone calls, (4\) not able to understand and speak German