Evaluation of an evidence-based guidance on the reduction of physical restraints in nursing homes
| ISRCTN | ISRCTN34974819 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34974819 |
| Secondary identifying numbers | Sponsor ref: 01GT0605 |
- Submission date
- 29/04/2009
- Registration date
- 29/05/2009
- Last edited
- 29/05/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Gabriele Meyer
Scientific
Scientific
University of Witten/Herdecke
Faculty for Medicine
Institute of Nursing Science
Witten
58453
Germany
| Phone | +49 (0)2302 926 317 |
|---|---|
| Gabriele.Meyer@uni-wh.de |
Study information
| Study design | Cluster-randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Evaluation of an evidence-based guidance on the reduction of physical restraints in nursing homes: a cluster-randomised controlled trial |
| Study acronym | EBAGRAP |
| Study objectives | The purpose of this study is to evaluate the clinical efficacy and safety of an intervention programme based on an evidence-based guidance on the reduction of physical restraints in nursing homes. We are specifically interested in whether the intervention can reduce the number of residents with at least one physical restraint at six months of follow-up. |
| Ethics approval(s) | 1. Ethics Committee of the Hamburg Chamber of Physicians approved on the 8th April 2009 (ref: PV3165) 2. Ethics Committee of the University of Witten/Herdecke approved on the 24th April 2009 |
| Health condition(s) or problem(s) studied | Physical restraints in nursing homes |
| Intervention | The intervention is based on an evidence-based guidance on the reduction of physical restraints in nursing homes, comprising 24 statements on relevant interventions to avoid physical restraints. The intervention consists of a structured single information session of approximately 90 minutes for all nursing staff, provision of written information material for nurses, legal guardians and residents' relatives and a one-day training workshop for nominated nurses of each cluster, who will be responsible for all issues concerning physical restraints. Nurses in charge of the control group receive personal and written brief standard information on legal and scientific evidence on physical restraints and alternatives aimed to avoid measures. |
| Intervention type | Other |
| Primary outcome measure | Number of residents with at least one physical restraint after six months of follow-up. Physical restraints are defined as any device, material or equipment attached to or near a person's body, which cannot be controlled easily or removed by the person and which deliberately prevents or is deliberately intended to prevent a person's free body movement to a position of choice. Prevalence data of physical restraints will be obtained by direct observation on three occasions on one day (morning, noon, evening) by trained external investigators, who are blinded to allocation of nursing homes. Data will be collected before randomisation, after three and after six months using a proven data collection instrument of a previous epidemiological study. |
| Secondary outcome measures | The number of falls and fall-related fractures. Nursing staff will document fall events within their in-house documentation system throughout the whole study period. If no documentation sheet for fall events exists it will be provided by the researchers. Data will be collected throughout the study period (6 months). |
| Overall study start date | 15/04/2009 |
| Completion date | 31/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 36 nursing homes (approximately 3,000 residents) |
| Key inclusion criteria | Nursing homes in the city of Hamburg and in surrounding cities of Witten/Herdecke with at least 20% of residents with physical restraints and at least 60 residents. All residents will be included. |
| Key exclusion criteria | Nursing homes with less than 20% of residents with physical restraints and less than 60 residents. |
| Date of first enrolment | 15/04/2009 |
| Date of final enrolment | 31/05/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
University of Witten/Herdecke
Witten
58453
Germany
58453
Germany
Sponsor information
German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)
Government
Government
Projektträger im DLR
Heinrich-Konen-Strasse 1
Bonn
53227
Germany
| Diana.Klassen@dlr.de | |
| Website | http://www.bmbf.de |
"ROR" |
https://ror.org/04pz7b180 |
Funders
Funder type
Government
German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)
No information available
Northern Germany Nursing Research Network (Germany) (ref: University of Hamburg: 01GT0605, University of Witten/Herdecke: 01GT0808)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 07/09/2009 | Yes | No | |
| Results article | results | 23/05/2012 | Yes | No |
