DementiaWISDENCT00653731
Effective Strategies for Dementia Care
A study testing Snoezelen ©, structured reminiscence therapy and 10-minutes activation in people with Dementia and Cognitive Impairment, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether the interventions of Snoezelen, structured reminiscence therapy and 10-minutes activation are effective to reduce apathy in long term care residents with dementia. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Dementia, Cognitive Impairment
- What is being tested?
- Snoezelen ©, structured reminiscence therapy and 10-minutes activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2008to Jan 2010
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dementia
- Informed consent by legal guardian
- MMSE ≤ 24
Who cannot join
- Korsakoff's syndrome
- Age ≤ 55 years
- Cognitive impairment other cause than dementia
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut für Gesundheits- und Pflegewissenschaft, Medizinische Fakultät, Martin-Luther-Universität Halle-Wittenberg
Halle, SAN, 06097
About this study
Official title: Testing Three Interventions for Clinical Effectiveness in Long Term Care Residents With Dementia: Snoezelen, Structured Reminiscence Therapy, 10-minutes Activation. A Cluster-randomized Controlled Trial.
The purpose of this study is to determine whether the interventions of Snoezelen, structured reminiscence therapy and 10-minutes activation are effective to reduce apathy in long term care residents with dementia.
Read the detailed description
Design:
Cluster-randomized controlled trial with 20 nursing homes in Saxony and Saxony-Anhalt (Germany).
- Conditions
- Dementia, Cognitive Impairment
- Being tested
- Snoezelen ©, structured reminiscence therapy, 10-minutes activation, Unstructured verbal communication
- Keywords
- dementia, snoezelen, structured reminiscence therapy, 10-minutes activation, apathy
- Medical subject headings
- Dementia, Cognitive Dysfunction, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Snoezelen ©Behavioural
Nursing individual intervention one time a week for 20 minutes
structured reminiscence therapyBehavioural
Individual nursing intervention: one time a week 20 minutes
10-minutes activationBehavioural
Individual nursing intervention: two times a week for 10 minutes
Unstructured verbal communicationBehavioural
Individual nursing intervention: one time a week for 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Snoezelen © | Experimental | Not described Receives: Behavioral: Snoezelen © |
| Reminiscence | Experimental | Not described Receives: Behavioral: structured reminiscence therapy |
| 10 min activation | Experimental | Not described Receives: Behavioral: 10-minutes activation |
| Talk | Active comparator | Not described Receives: Behavioral: Unstructured verbal communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apathy Evaluation Scale (Marin et al. 1991)
Measured: 12 months
Secondary outcomes (6)
Neuropsychiatric Inventory (Cummings 1997)
Measured: 3, 6 and 12 months
Apathy Evaluation Scale (Marin et al. 1991)
Measured: 3 and 6 months
Staff Observation Aggression Scale (Nijman et al. 1997)
Measured: 3,6 and 12 months
Nottingham Health Profile (Bureau-Chalot et al. 2002) staff-related measurement
Measured: 6 and 12 months
Smiley Analogue Scale for Well-Being
Measured: 3, 6 and 12 months
PASTA (Zimber 2001) staff-related measurement
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- None (open label)
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Johann Behrens, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Johann Behrens, PhD, Principal investigator, Martin-Luther-University Halle-Wittenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653731
- Sponsor's protocol ID
- PfVMS-T6
- Acronym
- WISDE
- Status last verified
- Aug 2011
- First submitted
- 2 Apr 2008
- Last updated
- 31 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Berg A, Sadowski K, Beyrodt M, Hanns S, Zimmermann M, Langer G, Becker C, Lautenschlager C, Behrens J. Snoezelen, structured reminiscence therapy and 10-minutes activation in long term care residents with dementia (WISDE): study protocol of a cluster randomized controlled trial. BMC Geriatr. 2010 Jan 31;10:5. doi: 10.1186/1471-2318-10-5.
PubMed 20113526
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Three Interventions for Clinical Effectiveness in Long Term Care Residents With Dementia: Snoezelen, Structured Reminiscence Therapy, 10-minutes Activation. A Cluster-randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00653731
- Acronym / sponsor ID
- WISDE / PfVMS-T6
- Conditions
- Dementia, Cognitive Impairment
- Keywords
- dementia, snoezelen, structured reminiscence therapy, 10-minutes activation, apathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Feb 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 7 Apr 2008 (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.
The purpose of this study is to determine whether the interventions of Snoezelen, structured reminiscence therapy and 10-minutes activation are effective to reduce apathy in long term care residents with dementia.
Detailed description
Design:
Cluster-randomized controlled trial with 20 nursing homes in Saxony and Saxony-Anhalt (Germany).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Snoezelen © | Experimental | Behavioral: Snoezelen © |
| Reminiscence | Experimental | Behavioral: structured reminiscence therapy |
| 10 min activation | Experimental | Behavioral: 10-minutes activation |
| Talk | Active comparator | Behavioral: Unstructured verbal communication |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Dementia
- Informed consent by legal guardian
- MMSE ≤ 24
Key exclusion criteria (3 listed)
- Korsakoff's syndrome
- Age ≤ 55 years
- Cognitive impairment other cause than dementia
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 |
|---|---|---|
| Snoezelen ©Nursing individual intervention one time a week for 20 minutes | Behavioural | Snoezelen © |
| structured reminiscence therapyIndividual nursing intervention: one time a week 20 minutes | Behavioural | Reminiscence |
| 10-minutes activationIndividual nursing intervention: two times a week for 10 minutes | Behavioural | 10 min activation |
| Unstructured verbal communicationIndividual nursing intervention: one time a week for 20 minutes | Behavioural | Talk |
Primary outcome
Apathy Evaluation Scale (Marin et al. 1991)
Time frame: 12 months
6 secondary outcomes
Neuropsychiatric Inventory (Cummings 1997)
Time frame: 3, 6 and 12 months
Apathy Evaluation Scale (Marin et al. 1991)
Time frame: 3 and 6 months
Staff Observation Aggression Scale (Nijman et al. 1997)
Time frame: 3,6 and 12 months
Nottingham Health Profile (Bureau-Chalot et al. 2002) staff-related measurement
Time frame: 6 and 12 months
Smiley Analogue Scale for Well-Being
Time frame: 3, 6 and 12 months
PASTA (Zimber 2001) staff-related measurement
Time frame: 6 and 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 31 Aug 2011.
- Derived from this study: PubMed 20113526Berg A, Sadowski K, Beyrodt M, Hanns S, Zimmermann M, Langer G, Becker C, Lautenschlager C, Behrens J. Snoezelen, structured reminiscence therapy and 10-minutes activation in long term care residents with dementia (WISDE): study protocol of a cluster randomized controlled trial. BMC Geriatr. 2010 Jan 31;10:5. doi: 10.1186/1471-2318-10-5.
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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.
Johann Behrens, PhD principal investigator
Martin-Luther-University Halle-Wittenberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Snoezelen ©, structured reminiscence therapy and 10-minutes activation in people with Dementia and Cognitive Impairment, run by Martin-Luther-Universität Halle-Wittenberg at 1 site 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 31 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Apathy Evaluation Scale (Marin et al. 1991) (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 NCT00653731, which also lists 1 linked publication.
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 31 Aug 2011.