Clinical trial NCT02655003: Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropscyhiatric Symptoms
Official title: TIME - Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropscyhiatric Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: behavioral symptoms
psychological symptoms
dementia
neuropsychiatric symptoms
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
First posted: 2016-01-13
Enrollment: 229
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Clinical Dementia Rating scale (CDR) 1 or higher.
2. Moderate to high grade of agitation defined by the NPI-NH agitation item as equal to or above six points.
3. Planned long-term stay in the nursing home, and a minimum of two weeks stay in the nursing home before inclusion.

Exclusion Criteria:

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

Primary outcomes:
measure: NPI-NH agitation/aggression
timeFrame: 8 weeks and 12 weeks
Secondary outcomes:
measure: NPI-NH all separate items
timeFrame: 8 weeks and 12 weeks
measure: NPI-NH sub syndrome agitation
timeFrame: 8 weeks and 12 weeks
measure: NPI-NH sub syndrome affective symptoms
timeFrame: 8 weeks and 12 weeks
measure: NPI-NH sub syndrome psychosis
timeFrame: 8 weeks and 12 weeks
measure: NPI-10 NH sum score
timeFrame: 8 weeks and 12 weeks
measure: The NPI-NH caregiver occupational disruptiveness score
timeFrame: 8 weeks and 12 weeks
measure: CMAI
timeFrame: 8 weeks and 12 weeks
measure: Lawton and Brody ADL scale
timeFrame: 8 weeks and 12 weeks
measure: The Cornell scale for depression in dementia CSDD
timeFrame: 8 weeks and 12 weeks
measure: Drug usage
timeFrame: 8 weeks and 12 weeks
measure: Quality of life measured by the scale QUALID
timeFrame: 8 weeks and 12 weeks
measure: General medical health using the General Medical Health Rating scale
timeFrame: 8 weeks and 12 weeks
Other outcomes:
Locations:
city: Ottestad
country: Norway
facility: Centre for Old Age Psychiatric Research, Sykehuset Innlandet Hospital Trust
Study officials:
affiliation: +4745679393
name: Sverre Bergh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.