DementiaIMPRINTNCT02341898
Implementation of a Multicomponent Intervention to Prevent Physical Restraints in Nursing Home Residents (IMPRINT)
A study testing Educational programme for all nurses, Training and structured support for nominated key nurses and Facultative train-the-trainer module for key nurses in people with Dementia, run by University of Luebeck at 4 sites in Germany.
Trial summary
Background: Physical restraints as bedrails and belts are still regularly applied in German nursing homes despite clear evidence showing their lack of effectiveness and safety. In a cluster-randomized controlled trial, the efficacy of a guideline-based multicomponent intervention has been shown with a significant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Educational programme for all nurses, Training and structured support for nominated key nurses and Facultative train-the-trainer module for key nurses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,800 participants
- Where
- 4 sitesGermany
- Study dates
- Mar 2015to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- randomly selected nursing homes in each region; no specific inclusion criteria will be applied
- all residents within the cluster present on the day of data collection
- all residents newly admitted to clusters during follow-up and present on the day of follow-up data collection
Who cannot join
- no specific exclusion criteria will be applied
- Individual level
- no specific exclusion criteria will be applied
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Martin-Luther-University Halle-Wittenberg
Halle, Saxony-Anhalt, 06112
University of Hamburg
Hamburg, 20146
University of Lübeck
Lübeck, Schleswig-Holstein, 23562
Witten/Herdecke University
Witten, North Rhine-Westphalia, 58448
About this study
Official title: Implementation of a Multicomponent Intervention to Prevent Physical Restraints in Nursing Home Residents: a Cluster-randomized Controlled Trial
Background: Physical restraints as bedrails and belts are still regularly applied in German nursing homes despite clear evidence showing their lack of effectiveness and safety. In a cluster-randomized controlled trial, the efficacy of a guideline-based multicomponent intervention has been shown with a significant reduction in physical restraints use without adverse events. The present study aims to apply different versions of the original intervention in nursing home residents in four different regions throughout Germany in order to evaluate the effectiveness of the programme.
Methods/Design: Pragmatic cluster-randomized controlled trial comparing two intervention groups ((1) updated original programme and (2) brief version of the updated programme) with a control group (3) receiving printed study materials (optimized usual care). Intervention (1) consists of an information programme for all nurses, additional training and structured support for nominated key nurses, and provision of printed study material and other supportive material. For intervention (2) nurses' training is only optional carried out facultatively by key nurses who have received an additional train-the-trainer module. The control group (3) receives printed study material only. Overall, 120 nursing homes including approximately 10800 residents will be recruited, randomized to one of the three groups and followed up for 12 months. The primary outcome is defined as proportion of residents with at least one physical restraint at 12 months. Physical restraint use will be assessed by direct observation. Secondary outcomes are residents' quality of life as well as safety parameters as i.g. falls and fall-related fractures. Process and cost measures will also be assessed.
- Conditions
- Dementia
- Being tested
- Educational programme for all nurses, Training and structured support for nominated key nurses, Facultative train-the-trainer module for key nurses, Printed study material, Supportive material (poster, mugs etc.)
- Keywords
- nursing home care, physical restraints, dementia, implementation research, cluster-randomized controlled trial
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational programme for all nursesOther
Training and structured support for nominated key nursesOther
Facultative train-the-trainer module for key nursesOther
Printed study materialOther
Supportive material (poster, mugs etc.)Other
| Study group | Role | What they receive |
|---|---|---|
| Updated original programme | Experimental | Educational programme for all nurses (90 min. single information session); training and structured support for nominated key nurses (one-day training workshop); provision of printed study material (evidence-based practice guideline; short versions for nurses, legal guardians, and others; information brochures for relatives); supportive material (poster, mugs etc.) Receives: Other: Educational programme for all nurses; Other: Training and structured support for nominated key nurses; Other: Printed study material; Other: Supportive material (poster, mugs etc.) |
| Concise updated programme | Experimental | Training and structured support for nominated key nurses (one-day training workshop); nurses' training will be carried out by key nurses as facultative option; key nurses receive an additional train-the-trainer module to apply the educational programme; provision of printed study material (evidence-based practice guideline; short versions for nurses, legal guardians, and others; information brochures for relatives); supportive material (poster, mugs etc.) Receives: Other: Training and structured support for nominated key nurses; Other: Facultative train-the-trainer module for key nurses; Other: Printed study material; Other: Supportive material (poster, mugs etc.) |
| Optimized usual care | Active comparator | Provision of printed study material (evidence-based practice guideline; short versions for nurses, legal guardians, and others; information brochures for relatives) only Receives: Other: Printed study material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of residents with at least one physical restraint assessed through direct observation by blinded research assistants
Measured: 12 Months
Secondary outcomes (3)
Residents' quality of life (measured by QoL-AD)
Will be measured by QoL-AD for a randomly selected subgroup of 10% of residents
Measured: 12 Months
Falls and fall-related fractures
Measured: 12 Months
Costs within trial period (cost parameters related to the implementation of the intervention as well as outcome-related cost parameters)
For economic evaluation cost parameters related to the implementation of the intervention will be collected as well as outcome-related costparameters; explicit trial-associated will not be taken into account
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Collaborators
- Martin-Luther-Universität Halle-Wittenberg
- Responsible party
- Principal investigator, Sascha Köpke, University of Luebeck
- Investigators
- Sascha Köpke, Prof. Dr., Principal investigator, University of Lübeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341898
- Sponsor's protocol ID
- IMPRINT
- Other IDs
- 01GY1336A, 01GY1336B
- Acronym
- IMPRINT
- Status last verified
- May 2017
- First submitted
- 16 Dec 2014
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Abraham J, Kupfer R, Behncke A, Berger-Hoger B, Icks A, Haastert B, Meyer G, Kopke S, Mohler R. Implementation of a multicomponent intervention to prevent physical restraints in nursing homes (IMPRINT): A pragmatic cluster randomized controlled trial. Int J Nurs Stud. 2019 Aug;96:27-34. doi: 10.1016/j.ijnurstu.2019.03.017. Epub 2019 Apr 4.
PubMed 31014546Abraham J, Mohler R, Henkel A, Kupfer R, Icks A, Dintsios CM, Haastert B, Meyer G, Kopke S. Implementation of a Multicomponent intervention to Prevent Physical Restraints In Nursing home residenTs (IMPRINT): study protocol for a cluster-randomised controlled trial. BMC Geriatr. 2015 Jul 21;15:86. doi: 10.1186/s12877-015-0086-0.
PubMed 26195247
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Multicomponent Intervention to Prevent Physical Restraints in Nursing Home Residents: a Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02341898
- Acronym / sponsor ID
- IMPRINT / IMPRINT
- Conditions
- Dementia
- Keywords
- nursing home care, physical restraints, dementia, implementation research, cluster-randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,800 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Collaborators
- Martin-Luther-Universität Halle-Wittenberg
- Study start
- Mar 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Physical restraints as bedrails and belts are still regularly applied in German nursing homes despite clear evidence showing their lack of effectiveness and safety. In a cluster-randomized controlled trial, the efficacy of a guideline-based multicomponent intervention has been shown with a significant reduction in physical restraints use without adverse events. The present study aims to apply different versions of the original intervention in nursing home residents in four different regions throughout Germany in order to evaluate the effectiveness of the programme.
Methods/Design: Pragmatic cluster-randomized controlled trial comparing two intervention groups ((1) updated original programme and (2) brief version of the updated programme) with a control group (3) receiving printed study materials (optimized usual care). Intervention (1) consists of an information programme for all nurses, additional training and structured support for nominated key nurses, and provision of printed study material and other supportive material. For intervention (2) nurses' training is only optional carried out facultatively by key nurses who have received an additional train-the-trainer module. The control group (3) receives printed study material only. Overall, 120 nursing homes including approximately 10800 residents will be recruited, randomized to one of the three groups and followed up for 12 months. The primary outcome is defined as proportion of residents with at least one physical restraint at 12 months. Physical restraint use will be assessed by direct observation. Secondary outcomes are residents' quality of life as well as safety parameters as i.g. falls and fall-related fractures. Process and cost measures will also be assessed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Updated original programme | Experimental | Other: Educational programme for all nurses, Other: Training and structured support for nominated key nurses, Other: Printed study material, Other: Supportive material (poster, mugs etc.)Educational programme for all nurses (90 min. single information session); training and structured support for nominated key nurses (one-day training workshop); provision of printed study material (evidence-based practice guideline; short versions for nurses, legal guardians, and others; information brochures for relatives); supportive material (poster, mugs etc.) |
| Concise updated programme | Experimental | Other: Training and structured support for nominated key nurses, Other: Facultative train-the-trainer module for key nurses, Other: Printed study material, Other: Supportive material (poster, mugs etc.)Training and structured support for nominated key nurses (one-day training workshop); nurses' training will be carried out by key nurses as facultative option; key nurses receive an additional train-the-trainer module to apply the educational programme; provision of printed study material (evidence-based practice guideline; short versions for nurses, legal guardians, and others; information brochures for relatives); supportive material (poster, mugs etc.) |
| Optimized usual care | Active comparator | Other: Printed study materialProvision of printed study material (evidence-based practice guideline; short versions for nurses, legal guardians, and others; information brochures for relatives) only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- randomly selected nursing homes in each region; no specific inclusion criteria will be applied
- all residents within the cluster present on the day of data collection
- all residents newly admitted to clusters during follow-up and present on the day of follow-up data collection
Key exclusion criteria (3 listed)
- no specific exclusion criteria will be applied
- Individual level
- no specific exclusion criteria will be applied
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational programme for all nurses | Other | Updated original programme |
| Training and structured support for nominated key nurses | Other | Concise updated programme, Updated original programme |
| Facultative train-the-trainer module for key nurses | Other | Concise updated programme |
| Printed study material | Other | Concise updated programme, Optimized usual care, Updated original programme |
| Supportive material (poster, mugs etc.) | Other | Concise updated programme, Updated original programme |
Primary outcome
Proportion of residents with at least one physical restraint assessed through direct observation by blinded research assistants
Time frame: 12 Months
3 secondary outcomes
Residents' quality of life (measured by QoL-AD)
Time frame: 12 Months
Falls and fall-related fractures
Time frame: 12 Months
Costs within trial period (cost parameters related to the implementation of the intervention as well as outcome-related cost parameters)
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Derived from this study: PubMed 31014546Abraham J, Kupfer R, Behncke A, Berger-Hoger B, Icks A, Haastert B, Meyer G, Kopke S, Mohler R. Implementation of a multicomponent intervention to prevent physical restraints in nursing homes (IMPRINT): A pragmatic cluster randomized controlled trial. Int J Nurs Stud. 2019 Aug;96:27-34. doi: 10.1016/j.ijnurstu.2019.03.017. Epub 2019 Apr 4.
- Derived from this study: PubMed 26195247Abraham J, Mohler R, Henkel A, Kupfer R, Icks A, Dintsios CM, Haastert B, Meyer G, Kopke S. Implementation of a Multicomponent intervention to Prevent Physical Restraints In Nursing home residenTs (IMPRINT): study protocol for a cluster-randomised controlled trial. BMC Geriatr. 2015 Jul 21;15:86. doi: 10.1186/s12877-015-0086-0.
- project homepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sascha Köpke, Prof. Dr. principal investigator
University of Lübeck
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational programme for all nurses, Training and structured support for nominated key nurses and Facultative train-the-trainer module for key nurses in people with Dementia, run by University of Luebeck at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of residents with at least one physical restraint assessed through direct observation by blinded research assistants (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02341898, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.