Clinical trial NCT04034680: Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms in Home Care Services
Official title: The TIME -Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms - for Continuity of Care in Home Care Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Behavioral symptoms
Dementia
Nevropsychiatric symptoms
Psychological symptoms
The TIME model
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized trial
Primary purpose: TREATMENT

Brief summary: Continuity of care in home care services is necessary to facilitate the assessment and treatment of persons with dementia and cognitive failure. TIME (Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms) is a multi-component intervention with a biopsychosocial approach, based on the theoretical framework of cognitive behavioral therapy and person-centred care. The trial is designed to assess the effects of TIME on Neuropsychiatric symptoms for persons (NPS) with dementia in home care services.

Detailed description: The Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms (TIME) is a multi-component intervention with a biopsychosocial approach, based on the theoretical framework of cognitive behavioral therapy and person-centred care. TIME consists of a manual based multicomponent program which includes a rigorous assessment, treatment, and the evaluation of neuropsychiatrc symptoms (NPS).

The cluster RCT will contain two parallel groups, where randomisation is performed based on clusters. One municipality is one cluster, randomized to receive either the intervention with TIME or a brief two hours education-only intervention about dementia and NPS for the control group. Totally 10 municipalities will be included. Data will be collected at baseline before randomisation and at the end of the implementing phase. Measurements at patient level are taken at baseline prior to randomization and after 6 months. The primary outcome measure is difference in change between the intervention group and the control group from baseline to follow up at 6 months in the Cornell Scale for Depression in Dementia (CSDD).

Data collection will be performed by project nurses recruited outside the home care services. They will interview the staff or family members who knows the patient best. The assessors will be blinded to the randomization of the home care services. Interviews will be done by telephone or face-to-face, depending on what is best for the person interviewed.

After the intervention focus group interviews with staff and family members will be conducted.

Eligibility criteria: Inclusion Criteria:

* Dementia, defined as a score of 1 or more on the Clinical Dementia Rating Scale (CDR)
* A minimum of 15 minutes of home care services per day for the last 4 weeks
* NPS, defined as a score on the NPI-NH affective subsyndrom (NPI depression + NPI anxiety) of 12 or more
* Informed consent from the participant or family or next-of-kin

Exclusion Criteria:

* Terminal disease

Primary outcomes:
measure: Affective symptoms measured by the Cornell Scale for Depression in Dementia (CSDD)
timeFrame: 6 months
Secondary outcomes:
measure: Neuropsychiatric Inventory - nursing home version (NPI-NH): Sub syndrome anxiety and depression
timeFrame: 6 months
measure: NPI-NH: all separate items
timeFrame: 6 months
measure: NPI-NH: caregiver distress score
timeFrame: 6 months
measure: Quality of life measured by the scale QUALID
timeFrame: 6 months
measure: Change in Relatives Stress scale Score (RSS)
timeFrame: 6 months
measure: Transferring to nursing home
timeFrame: 12 months
measure: Minimal data set (MDS): patient rejection of care
timeFrame: 6 months
Other outcomes:
Locations:
city: Ottestad
country: Norway
facility: The Research centre for Age-related Functional decline and Disease (AFS) at Innlandet Hospital Trust
Study officials:
affiliation: The Research centre for Age-related Functional decline and Disease (AFS)
name: Sverre Bergh, PhD
role: PRINCIPAL_INVESTIGATOR
References: