Condition category
Injury, Occupational Diseases, Poisoning
Date applied
21/04/2011
Date assigned
06/06/2011
Last edited
20/02/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Klaus Pfeiffer

ORCID ID

Contact details

Geriatrisches Kompetenzzentrum
Robert-Bosch-Krankenhaus
Auerbachstr. 110
Stuttgart
70376
Germany
klaus.pfeiffer@rbk.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01EC1007A

Study information

Scientific title

Multifactorial intervention to reduce fear of falling after a hip or pelvic fracture: a prospective, randomised controlled trial - subproject No. 5 of the consortium “Prevention and Rehabilitation of Osteoporotic Fractures in Disadvantaged Populations”

Acronym

PROFinD 5

Study hypothesis

Main hypothesis: Rehabilitation + fear of falling - intervention are more effective than standard inpatient rehabilitation in regard to physical activity and falls efficacy three months after discharge.
Minor Hypothesis: To determine the effect of the intervention on fear of falling, perceived control over falling, depression, general anxiety, quality of life and functional recovery three months after discharge.

Ethics approval

The ethics committee of the University of Tuebingen, Germany approved on 4th April 2011 (ref: 113/2011BO2).

Study design

Prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Hip or pelvic fracture

Intervention

Intervention group
Multifactorial intervention to increase physical activity and reduce fear of falling. It comprises of 8 additional personal contacts during the inpatient rehabilitation period, 4 telephone contacts and one home visit during two months after discharge.

The intervention consists of six modules:
1. Training of a relaxation technique
2. Objectives in mobility and plan to reach them
3. Fall-related cognitions and emotions, managing critical situations
4. Individual exercise programme
5. Realising exercises and activities regulary at home
6. Fall hazards

Intervention and control group:
All participants receive standard inpatient rehabilitation.

Interventions and assessments are delivered by different teams; the assessment team is blinded to the different groups by the study centre. Because communicating of their status by the participants a complete blinding is probably not possible.

Contact details of the Principal Investigator
Prof. Martin Hautzinger
Abteilung für Klinische Psychologie und Entwicklungspsychologie
Universität Tübingen
Christophstr. 2
72072 Tübingen
email : hautzinger@uni-tuebingen.de

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Physical activity
1.1. Sensor based activity monitoring
1.2. Phone-FITT– physical activity questionnaire
2. Falls Efficacy
2.1. Short Falls Efficacy Scale international [Short FES-I]
2.2. Perceived ability to manage risk of falls or actual falls
Measured at: T0: in the first week after admission to inpatient rehabilitation, T1: between two weeks after T0 and discharge, T2: 4 months after T0

Secondary outcome measures

1. Fall-related Criteria - Percived Control Over Falling [PCOF]
2. Mental Health Criteria
2.1. Hospital Anxiety & Depression Scale [HADS]
2.2. Revised Anxiety Control Questionnaire subscale “emotion” and “stress” [ACQ-R]
2.3. Revised Acceptance and Action Questionnaire II [AAQ-II]
3. Body Functions
3.1. Short Physical Performance Battery [SPPB]
3.2. Rivermead Mobility Index
4. Quality of life
4.1. EURO QoL-5
4.2. WHO-QoL Old, subscale “social participation”

Measured at: T0: in the first week after admission to inpatient rehabilitation, T1: between two weeks after T0 and discharge, T2: 4 months after T0

Overall trial start date

26/04/2011

Overall trial end date

31/08/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 20/02/2012:
1. Hip or pelvic fracture as main diagnosis for admission to inpatient rehabilitation
2. Age: 60 years and older
3. Concern about falling (Fear of Falling screening instrument)

Previous inclusion criteria:
1. Hip or pelvic fracture within the last 8 weeks
2. Age: 60 years and older
3. Concern about falling (Fear of Falling screening instrument)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

102 participants

Participant exclusion criteria

1. Delirium
2. Shortsightedness (> 20/400)
3. Mental disease like suicidality, acute psychosis, schizophrenia, bipolar disorder, schizo-affective disorder
4. Cognitive impairment Short Orientation-Memory-Concentration (SOMC) ≥ 10
5. Living in a nursing home when the fall occured
6. Not able to understand and speak German language
7. No telephone extension or not able to communicate over the telephone
8. Moderate or severe aphasia (amnesic aphasia is no exclusion criteria), apraxia of speech
9. Capacity too low to endure the assessment
10. Diseases, that require additional time-consuming therapy during rehabilitation period (like dialysis)
11. Other medical exclusion criterias like severe inflammations or infections, mechanical instability of the osteosynthesis, terminal status
12. Place of domicile not reachable with the public transport of the region of Stuttgart

Recruitment start date

26/04/2011

Recruitment end date

31/08/2013

Locations

Countries of recruitment

Germany

Trial participating centre

Geriatrisches Kompetenzzentrum
Stuttgart
70376
Germany

Sponsor information

Organisation

Robert Bosch Hospital (Robert-Bosch-Krankenhaus) (Germany)

Sponsor details

c/o Dr. Clemens Becker
Geriatrisches Kompetenzzentrum
Auerbachstr. 110
Stuttgart
70376
Germany

Sponsor type

Hospital/treatment centre

Website

http://www.rbk.de/

Funders

Funder type

Government

Funder name

Federal Ministry of Education and Research (BMBF) (Germany) (ref:01EC1007A)

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes