Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms in Home Care Services
NCT ID: NCT04034680
Last Updated: 2020-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2019-02-01
2020-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Home care services - Intervention group
Totally 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.
TIME
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.
Home care services - Control group
Totally 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.
Education-only 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.
Interventions
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TIME
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.
Education-only 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
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Inclusion Criteria
* 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
65 Years
ALL
No
Sponsors
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Sykehuset Innlandet HF
OTHER
Responsible Party
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Principal Investigators
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Sverre Bergh, PhD
Role: PRINCIPAL_INVESTIGATOR
The Research centre for Age-related Functional decline and Disease (AFS)
Locations
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The Research centre for Age-related Functional decline and Disease (AFS) at Innlandet Hospital Trust
Ottestad, , Norway
Countries
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Other Identifiers
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SI0303150608
Identifier Type: -
Identifier Source: org_study_id
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