DementiaTIMENCT02655003
Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropscyhiatric Symptoms
A study testing TIME and Education-only intervention in people with Dementia, run by Sykehuset Innlandet HF at 1 site in Norway.
Trial summary
Almost all people who suffer from dementia experience neuropsychiatric symptoms (NPS) in the course of the disease. TIME (Targeted Interdisciplinary Model for Evaluation and treatment of neuropsychiatric symptoms) is a multicomponent intervention based on the theoretical framework of cognitive behavioral therapy… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- What is being tested?
- TIME and Education-only intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteNorway
- Study dates
- 7 Jan 2016to Jul 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical Dementia Rating scale (CDR) 1 or higher.
- Moderate to high grade of agitation defined by the NPI-NH agitation item as equal to or above six points.
- Planned long-term stay in the nursing home, and a minimum of two weeks stay in the nursing home before inclusion.
Who cannot join
- 1.Terminal phase (life expectancy less than 4-6 weeks)
Trial locations and contacts
1 site in 1 country.
Norway1 site
Centre for Old Age Psychiatric Research, Sykehuset Innlandet Hospital Trust
Ottestad, 2312
About this study
Official title: TIME - Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropscyhiatric Symptoms
Almost all people who suffer from dementia experience neuropsychiatric symptoms (NPS) in the course of the disease. TIME (Targeted Interdisciplinary Model for Evaluation and treatment of neuropsychiatric symptoms) is a multicomponent intervention based on the theoretical framework of cognitive behavioral therapy (CBT). The TIME trial is designed to assess the effects of TIME on NPS in nursing homes patients with dementia and the implementation process at staff and organization level.
Read the detailed description
TIME (Targeted Interdisciplinary Model for Evaluation and treatment of neuropsychiatric symptoms) is a multicomponent intervention based on the theoretical framework of cognitive behavioral therapy (CBT).The TIME trial includes a three months cluster randomized trial in 36 nursing homes with 164 participants with dementia and a high level of agitation. Each nursing home defines a cluster and will be randomized to receive either the intervention with TIME or a brief two hours education-only intervention about dementia and NPS for the control group. TIME consists of a manual based multicomponent program which includes a rigorous assessment, the treatment, and the evaluation of neuropsychiatrc symptoms (NPS). The staff, physicians and nursing home managers receive a one-day education. Three nurses from each unit will receive further education including practical and theoretical training for three hours. Measurements at patient level are taken at baseline prior to randomization and at eight and twelve weeks. The primary outcome measure is agitation. Mixed methods will be used to follow, measure and explore the implementation process and the effect at individual staff level and at organization level.
- Conditions
- Dementia
- Being tested
- TIME, Education-only intervention
- Keywords
- behavioral symptoms, psychological symptoms, dementia, neuropsychiatric symptoms
- Medical subject headings
- Dementia, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIMEOther
Also called Targeted Interdisciplinary Model for Evaluation and treatment of neuropsychiatric symptoms
Education-only interventionOther
The staff and physicians in the control nursing homes will receive a 2 hours education session about dementia and neuropsychiatric symptoms
| Study group | Role | What they receive |
|---|---|---|
| INH (Intervention Nursing Homes) | Experimental | TIME consists of a manual based multicomponent program which includes a rigorous assessment, the treatment, and the evaluation of NPS. The staff, physicians and nursing home managers in the intervention nursing homes will receive a one-day education program. Three nurses from each unit will receive further education including practical and theoretical training for three hours. Receives: Other: TIME |
| CNH (Control Nursing Homes) | Active comparator | A brief two hours education-only intervention about dementia and NPS will be given to the staff in for the control nursing homes (CNH). The staff and physicians in the control nursing homes continue practice as usual. Receives: Other: Education-only intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPI-NH agitation/aggression
The primary outcome measure is change from baseline of agitation and aggression as defined by the Neuropsychiatric Inventory Nursing Home Version (NPI-NH) item agitation/aggression.
Measured: 8 weeks and 12 weeks
Secondary outcomes (12)
NPI-NH all separate items
The change from baseline of the remaining 11 items in the.Neuropsychiatric Inventory Nursing Home Version (NPI-NH).
Measured: 8 weeks and 12 weeks
NPI-NH sub syndrome agitation
The change from baseline of the NPI-NH sub syndrome agitation is defined as the sum of the items agitation/aggression, irritability, and disinhibition in the NPI-NH.
Measured: 8 weeks and 12 weeks
NPI-NH sub syndrome affective symptoms
The change from baseline of the NPI-NH sub syndrome affective symptoms is defined as the sum of the items depression and anxiety in the in the NPI-NH.
Measured: 8 weeks and 12 weeks
NPI-NH sub syndrome psychosis
The change from baseline of the NPI-NH sub syndrome psychosis is defined as the sum of the items hallucinations and delusions items in the in the NPI-NH.
Measured: 8 weeks and 12 weeks
NPI-10 NH sum score
The change from baseline of the NPI-10 NH sum score is the sum of the first ten items in the Neuropsychiatrc Inventory Nursing Homes version
Measured: 8 weeks and 12 weeks
The NPI-NH caregiver occupational disruptiveness score
In the Neuropsychiatric Inventory Nursing Home Version (NPI-NH) the caregiver must rate how disruptive they find each behavior or symptom on a five point scale. The outcome is the change from baseline.
Measured: 8 weeks and 12 weeks
CMAI
The change from baseline in the Cohen-Mansfield Agitation Inventory (CMAI) within its 29 different types of agitation and the frequency at which they occur.
Measured: 8 weeks and 12 weeks
Lawton and Brody ADL scale
The change from baseline in the The Lawton and Brody ADL scale which describes 6 domains of activity of daily living with a score from 1 to 5 where 1 means no need for help and 5 means significant need for assistance.
Measured: 8 weeks and 12 weeks
The Cornell scale for depression in dementia CSDD
The change from baseline in The Cornell scale for depression which measures the frequency of symptoms of depression.
Measured: 8 weeks and 12 weeks
Drug usage
The change in drug dosage from baseline: that is the use of psychotropic and analgesic medication both as given regularly and on demand. This will be assessed using a questionnaire.
Measured: 8 weeks and 12 weeks
Quality of life measured by the scale QUALID
The change from baseline in quality of life which will be assessed by the scale QUALID: Quality of life in late-stage dementia scale disease.
Measured: 8 weeks and 12 weeks
General medical health using the General Medical Health Rating scale
The change from baseline in general medical health will be assessed by using the General Medical Health Rating scale (GMHR)
Measured: 8 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study start7 Jan 2016
- Primary completion1 Jul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sverre Bergh, PhD, Principal investigator, +4745679393
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655003
- Sponsor's protocol ID
- 150333
- Acronym
- TIME
- Status last verified
- Oct 2016
- First submitted
- 6 Jan 2016
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Myhre J, Lichtwarck B. How and why does it work? A video-based qualitative analysis of case conferences to reduce BPSD through the lens of Habermas's theory of communicative action. BMC Psychiatry. 2024 Jul 22;24(1):520. doi: 10.1186/s12888-024-05959-x.
PubMed 39039488Lichtwarck B, Myhre J, Selbaek G, Kirkevold O, Rokstad AMM, Benth JS, Bergh S. TIME to reduce agitation in persons with dementia in nursing homes. A process evaluation of a complex intervention. BMC Health Serv Res. 2019 May 31;19(1):349. doi: 10.1186/s12913-019-4168-0.
PubMed 31151437Lichtwarck B, Selbaek G, Kirkevold O, Rokstad AM, Benth JS, Myhre J, Nybakken S, Bergh S. TIME - Targeted interdisciplinary model for evaluation and treatment of neuropsychiatric symptoms: protocol for an effectiveness-implementation cluster randomized hybrid trial. BMC Psychiatry. 2016 Jul 12;16:233. doi: 10.1186/s12888-016-0944-0.
PubMed 27406242
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TIME - Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropscyhiatric Symptoms
- ClinicalTrials.gov ID
- NCT02655003
- Acronym / sponsor ID
- TIME / 150333
- Conditions
- Dementia
- Keywords
- behavioral symptoms, psychological symptoms, dementia, neuropsychiatric symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Study start
- 7 Jan 2016 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 13 Jan 2016 (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.
Almost all people who suffer from dementia experience neuropsychiatric symptoms (NPS) in the course of the disease. TIME (Targeted Interdisciplinary Model for Evaluation and treatment of neuropsychiatric symptoms) is a multicomponent intervention based on the theoretical framework of cognitive behavioral therapy (CBT). The TIME trial is designed to assess the effects of TIME on NPS in nursing homes patients with dementia and the implementation process at staff and organization level.
Detailed description
TIME (Targeted Interdisciplinary Model for Evaluation and treatment of neuropsychiatric symptoms) is a multicomponent intervention based on the theoretical framework of cognitive behavioral therapy (CBT).The TIME trial includes a three months cluster randomized trial in 36 nursing homes with 164 participants with dementia and a high level of agitation. Each nursing home defines a cluster and will be randomized to receive either the intervention with TIME or a brief two hours education-only intervention about dementia and NPS for the control group. TIME consists of a manual based multicomponent program which includes a rigorous assessment, the treatment, and the evaluation of neuropsychiatrc symptoms (NPS). The staff, physicians and nursing home managers receive a one-day education. Three nurses from each unit will receive further education including practical and theoretical training for three hours. Measurements at patient level are taken at baseline prior to randomization and at eight and twelve weeks. The primary outcome measure is agitation. Mixed methods will be used to follow, measure and explore the implementation process and the effect at individual staff level and at organization level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INH (Intervention Nursing Homes) | Experimental | Other: TIMETIME consists of a manual based multicomponent program which includes a rigorous assessment, the treatment, and the evaluation of NPS. The staff, physicians and nursing home managers in the intervention nursing homes will receive a one-day education program. Three nurses from each unit will receive further education including practical and theoretical training for three hours. |
| CNH (Control Nursing Homes) | Active comparator | Other: Education-only interventionA brief two hours education-only intervention about dementia and NPS will be given to the staff in for the control nursing homes (CNH). The staff and physicians in the control nursing homes continue practice as usual. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical Dementia Rating scale (CDR) 1 or higher.
- Moderate to high grade of agitation defined by the NPI-NH agitation item as equal to or above six points.
- Planned long-term stay in the nursing home, and a minimum of two weeks stay in the nursing home before inclusion.
Key exclusion criteria (1 listed)
- 1.Terminal phase (life expectancy less than 4-6 weeks)
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 |
|---|---|---|
| TIMEAlso: Targeted Interdisciplinary Model for Evaluation and treatment of neuropsychiatric symptoms | Other | INH (Intervention Nursing Homes) |
| Education-only interventionThe staff and physicians in the control nursing homes will receive a 2 hours education session about dementia and neuropsychiatric symptoms | Other | CNH (Control Nursing Homes) |
Primary outcome
NPI-NH agitation/aggression
Time frame: 8 weeks and 12 weeks
The primary outcome measure is change from baseline of agitation and aggression as defined by the Neuropsychiatric Inventory Nursing Home Version (NPI-NH) item agitation/aggression.
12 secondary outcomes
NPI-NH all separate items
Time frame: 8 weeks and 12 weeks
NPI-NH sub syndrome agitation
Time frame: 8 weeks and 12 weeks
NPI-NH sub syndrome affective symptoms
Time frame: 8 weeks and 12 weeks
NPI-NH sub syndrome psychosis
Time frame: 8 weeks and 12 weeks
NPI-10 NH sum score
Time frame: 8 weeks and 12 weeks
The NPI-NH caregiver occupational disruptiveness score
Time frame: 8 weeks and 12 weeks
CMAI
Time frame: 8 weeks and 12 weeks
Lawton and Brody ADL scale
Time frame: 8 weeks and 12 weeks
The Cornell scale for depression in dementia CSDD
Time frame: 8 weeks and 12 weeks
Drug usage
Time frame: 8 weeks and 12 weeks
Quality of life measured by the scale QUALID
Time frame: 8 weeks and 12 weeks
General medical health using the General Medical Health Rating scale
Time frame: 8 weeks and 12 weeks
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 15 Feb 2017.
- Derived from this study: PubMed 39039488Myhre J, Lichtwarck B. How and why does it work? A video-based qualitative analysis of case conferences to reduce BPSD through the lens of Habermas's theory of communicative action. BMC Psychiatry. 2024 Jul 22;24(1):520. doi: 10.1186/s12888-024-05959-x.
- Derived from this study: PubMed 31151437Lichtwarck B, Myhre J, Selbaek G, Kirkevold O, Rokstad AMM, Benth JS, Bergh S. TIME to reduce agitation in persons with dementia in nursing homes. A process evaluation of a complex intervention. BMC Health Serv Res. 2019 May 31;19(1):349. doi: 10.1186/s12913-019-4168-0.
- Derived from this study: PubMed 27406242Lichtwarck B, Selbaek G, Kirkevold O, Rokstad AM, Benth JS, Myhre J, Nybakken S, Bergh S. TIME - Targeted interdisciplinary model for evaluation and treatment of neuropsychiatric symptoms: protocol for an effectiveness-implementation cluster randomized hybrid trial. BMC Psychiatry. 2016 Jul 12;16:233. doi: 10.1186/s12888-016-0944-0.
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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.
Sverre Bergh, PhD principal investigator
+4745679393
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIME and Education-only intervention in people with Dementia, run by Sykehuset Innlandet HF at 1 site in Norway.
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 1 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 15 Feb 2017. 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 Norway. 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?
NPI-NH agitation/aggression (time frame: 8 weeks and 12 weeks). 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 NCT02655003, which also lists 3 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 15 Feb 2017.