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

Inclusion criteria: 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: 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 Hip / pelvic fracture # Incipient‐ to moderate‐stage cognitive impairment (Score Mini Mental State Examination: 17‐26);S72.2 ‐ Subtrochanteric fracture;S32.1 ‐ Fracture of sacrum;S32.2 ‐ Fracture of coccyx;S72.0 ‐ Fracture of neck of femur;S72.1 ‐ Pertrochanteric fracture;S32.3 ‐ Fracture of ilium;S32.4 ‐ Fracture of acetabulum;S32.5 ‐ Fracture of pubis;S32.7 ‐ Multiple fractures of lumbar spine and pelvis;S32.8 ‐ Fracture of other and unspecified parts of lumbar spine and pelvis Intervention 1: Intervention group: ‐ Standard inpatient rehabilitation with training ‐ Additional information about motor training and activity after hip or pelvic fractures (one contact during rehabilitation) including a brochure containing a standardized exercise program after hip or pelvic fractures ‐ Information about the program ‐ Usual non‐controlled care including physiotherapy, if prescribed by attending physician after discharge ‐ Multifactorial intervention to increase physical activity and improve functional performance. The intervention consists of the interventions mentioned above and the following two modules: Module 1: Training intervention [duration: 4 months; delivered by exercise instructor (EI) & volunteer instructor (VI)] over 4 months after discharge: ‐ Information about the intervention after randomization; training starts after the assessment T1b ‐ Assessment of mobility and independency, definition of mobility and participation goals, introduction of the VI, provision and introduction of and individual training program, clarifying / discussion of security aspects during training, reduction of fall risk in daily life, information on what to do after a fall ‐ Exercise program, 2 times per week for approx. 30 minutes (+ practice of a defined activity of daily living), supervised by VI (VI supervised by EI in home visits), maximum duration of a visit is 2 hours ‐ Unsupervised home training, 1 ‐ 4 times per week for approx. 10‐20 minutes, depending on the capacity of the patient and caregiver support ‐ Initial home visit (maximum duration: 2 hours) and 2 additional home visits (EI + VI) ‐ 5 telephone calls (EI) Module 2: Care counseling with a focus on promotion of activity and participation (duration: 3.5 months) ‐ Implemented by social worker ‐ Starts 1‐4 weeks after the first home visit by the EI Hip / pelvic fracture patient: ‐ Clarifying of care situation (modified Care Counselling Inventory; Hendlmeier et al. 20 4) ‐ Promoti Patient‐related measures: 1. Physical activity ‐ Sensor based activity monitoring (activPAL™, 72 hours) Measured at: T1b (at home, after rehabilitation), T2 (after the 4‐month program), T3 (follow‐u; three months after completion of the program) 2. Physical Performance ‐ Short Physical Performance Battery (SPPB; DynaPort) 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) 1. Patient‐related measures: ‐ Falls self‐efficacy / Fear of falling: Short Falls Efficacy Scale international (Short FES‐I), Fear of Falling Questionnaire Revised (FFQ‐R) ‐ **Falls: Falls diary / weekly telephone call ‐ Depressive symptoms: Montgomery‐Asberg Depression Scale (MADRS) ‐ Activities of daily life: *Barthel‐Index, and **study specific questions ‐ Health related quality of life: **Quality of Life in Alzheimer’s Disease (Qol‐AD) Other: ‐ Participation: Social Support Questionnaire (F‐SozU: modified part B) ‐ Pain: body chart, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) ‐Cognition: Nuremberg Aging Inventory (NAI), subcategory: repeating numbers Economic evaluation: ‐ Health related quality of life: EuroQol (EQ‐5D) ‐ Evaluation of additional therapies, inpatient stays, and support by care services 2. Caregiver‐related measures (if existing): ‐ ** Depressive symptoms: Centre for Epidemiological Studies – Depression Scale (CES‐D) ‐ ** Sense of competence: Sense of competence questionnaire – short version (SCQ ‐ subscale 2: self‐efficacy) ‐ ** Negative problem orientation: Social Problem‐Solving Inventory – Revised (SPSI‐R, subscale negative problem orientation) ‐ ** Subjective physical symptoms: Giessen Subjective Complaints List (GBB‐24, subscale pain in the limbs) ‐ ** Leisure time satisfaction: Leisure time satisfaction (LTS, subscale frequency) ‐ ** External assessment of behavioral problems of the patient: Revised Memory and Behaviour Problems Checklist (RMBPC, subscale frequency) Economic evaluation: ‐ ** Subjective health related quality of life: Carer‐related quality of life questionnaire (Carer‐Qol) ‐ Evaluation of additional therapies, inpatient stays ‐ Informal nursing / care activities 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) * only measured at T1a and T3 ** Not measured at T1a In addition: interventional costs (economic evaluation)