Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms in Home Care Services
The TIME -Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms - for Continuity of Care in Home Care Services
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2019
CompletedFirst Submitted
Initial submission to the registry
July 24, 2019
CompletedFirst Posted
Study publicly available on registry
July 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedSeptember 29, 2020
September 1, 2020
1.4 years
July 24, 2019
September 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Affective symptoms measured by the Cornell Scale for Depression in Dementia (CSDD)
The change from baseline of affective symptoms as defined in the Cornell Scale for Depression in Dementia (CSDD), a scale ranging from 0-38 where a higher score indicates more severe depressive symptoms.
6 months
Secondary Outcomes (7)
Neuropsychiatric Inventory - nursing home version (NPI-NH): Sub syndrome anxiety and depression
6 months
NPI-NH: all separate items
6 months
NPI-NH: caregiver distress score
6 months
Quality of life measured by the scale QUALID
6 months
Change in Relatives Stress scale Score (RSS)
6 months
- +2 more secondary outcomes
Study Arms (2)
Home care services - Intervention group
EXPERIMENTALTotally 5 municipalities (25 persons with dementia) will be included in the intervention group, and will receive training in the TIME model. This includes two hours of lectures about dementia and neuropsychiatric symptoms (NPS) and three hours of training and roleplay in using the TIME model. The staff of the home care service will receive the TIME manual and access to the TIME website with access to additional educational and information files. From each municipality, three staff members, called TIME administrators, will receive additional three hours of lectures and roleplay in TIME, and will thereafter have the responsibility for performing the intervention.
Home care services - Control group
ACTIVE COMPARATORTotally 5 municipalities (25 persons with dementia) will be included in the Control group. The municipalities in the control group will receive the same two hours lectures about dementia and NPS as the intervention group. After the cluster RCT pilot study is ended, municipalities in the control group will receive the same three-hour lessons in the TIME as the intervention group of municipalities.
Interventions
The intervention of the TIME model includes two hours of lectures about dementia and NPS and three hours of training and roleplay in using TIME. The staff of the home care service will receive the TIME manual and access to the TIME website with access to additional educational materials. From each municipality, three staff members called TIME administrators, will receive additional three hours of lectures and roleplay in TIME, and will thereafter have the responsibility for performing the intervention.
Staff in the home care service in municipalities in the control group will receive thesame two hours lectures about dementia and NPS as the intervention grorp. After the cluster RCT pilot study is ended, municipalities in the control group will receive the same three-hour lessons in the TIME as the intervention group of municipalities.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Terminal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Research centre for Age-related Functional decline and Disease (AFS) at Innlandet Hospital Trust
Ottestad, 2312, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sverre Bergh, PhD
The Research centre for Age-related Functional decline and Disease (AFS)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will be masked for the study arm they are randomised to. Staff in the home care service are aware of the study arm their patients are in, while assessors that will interview home care staff by telephone are masked for study randomisation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2019
First Posted
July 26, 2019
Study Start
February 1, 2019
Primary Completion
June 15, 2020
Study Completion
June 30, 2020
Last Updated
September 29, 2020
Record last verified: 2020-09