Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms in Home Care Services

Dementia Clinical Trial

Official title:

The TIME -Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms - for Continuity of Care in Home Care Services

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04034680
• Other study ID #: SI0303150608
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: September 2020
• Source: Sykehuset Innlandet HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Norway	The Research centre for Age-related Functional decline and Disease (AFS) at Innlandet Hospital Trust	Ottestad

Sponsors (1)

Lead Sponsor	Collaborator
Sykehuset Innlandet HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Neuropsychiatric Inventory - nursing home version (NPI-NH): Sub syndrome anxiety and depression	The change from baseline in the sub syndrome affective symptoms of the single items anxiety and depression as measured with the NPI-NH. Each single item is scored from 0-12, where a higher score indicates a more severe symptom.	6 months
Secondary	NPI-NH: all separate items	The change from baseline of the NPI-NH, scores on all the 12 items. Each single item is scored from 0-12, where a higher score indicates a more severe symptom.	6 months
Secondary	NPI-NH: caregiver distress score	The change from baseline in caregiver distress by the NPI-NH caregiver distress score. The caregiver distress on each NPI-NH item is scored from 0-5, where a higher score indicates more severe distress	6 months
Secondary	Quality of life measured by the scale QUALID	The change from baseline in quality of life by whitch will be assessed by the scale QUALID: Quality of life in late-stage dementia scale, a scale consisting of 11 single items scored from 1-5 (total score 11-55) where a lower score indicates a better QoL.	6 months
Secondary	Change in Relatives Stress scale Score (RSS)	The change in relatives stress assessed by the scale RSS: Relatives Stress scale Score, a scale ranging from 0-60 where a higher score indicates more severe distress	6 months
Secondary	Transferring to nursing home	To measure the number of patients transferring to nursing home during follow up.	12 months
Secondary	Minimal data set (MDS): patient rejection of care	The change in the patients rejection of care assessed by MDS: Minimal dataset (MDS)	6 months