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
- Conditions
- Hip / pelvic fractureIncipient- to moderate-stage cognitive impairment (Score Mini Mental State Examination: 17-26)S72.0S72.1S72.2S32.1S32.2S32.3S32.4S32.5S32.7
- Registration Number
- DRKS00008863
- Lead Sponsor
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 240
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient-related measures:<br>1. Physical activity <br>- Sensor based activity monitoring (activPAL™, 72 hours)<br><br>Measured at: T1b (at home, after rehabilitation), T2 (after the 4-month program), T3 (follow-u; three months after completion of the program)<br><br>2. Physical Performance<br>- Short Physical Performance Battery (SPPB; DynaPort)<br><br>Measured at: T1a (at the end of the rehabilitation), T1b (at home, after rehabilitation), T2 (after the 4-month program), T3 (follow-u; three months after completion of the program) <br>
- Secondary Outcome Measures
Name Time Method