NCT02655003

Brief 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 (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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
229

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

January 7, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

February 15, 2017

Status Verified

October 1, 2016

Enrollment Period

6 months

First QC Date

January 6, 2016

Last Update Submit

February 14, 2017

Conditions

Dementia

Keywords

behavioral symptomspsychological symptomsdementianeuropsychiatric symptoms

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 weeks and 12 weeks

Secondary Outcomes (12)

  • NPI-NH all separate items

    8 weeks and 12 weeks

  • NPI-NH sub syndrome agitation

    8 weeks and 12 weeks

  • NPI-NH sub syndrome affective symptoms

    8 weeks and 12 weeks

  • NPI-NH sub syndrome psychosis

    8 weeks and 12 weeks

  • NPI-10 NH sum score

    8 weeks and 12 weeks

  • +7 more secondary outcomes

Study Arms (2)

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.

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.

Other: Education-only intervention

Interventions

TIMEOTHER
Also known as: Targeted Interdisciplinary Model for Evaluation and treatment of neuropsychiatric symptoms
INH (Intervention Nursing Homes)
Education-only interventionOTHER

The staff and physicians in the control nursing homes will receive a 2 hours education session about dementia and neuropsychiatric symptoms

CNH (Control Nursing Homes)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Terminal phase (life expectancy less than 4-6 weeks)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Old Age Psychiatric Research, Sykehuset Innlandet Hospital Trust

Ottestad, 2312, Norway

Location

Related Publications (3)

  • 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.

    PMID: 39039488DERIVED

  • Lichtwarck 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.

    PMID: 31151437DERIVED

  • Lichtwarck 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.

    PMID: 27406242DERIVED

MeSH Terms

Conditions

DementiaBehavioral Symptoms

Interventions

Time

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

  • Sverre Bergh, PhD

    +4745679393

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2016

First Posted

January 13, 2016

Study Start

January 7, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

February 15, 2017

Record last verified: 2016-10

Locations

NO(1)