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

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
TIME
Education-only intervention
Sponsored by
Sykehuset Innlandet HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring Behavioral symptoms, Dementia, Nevropsychiatric symptoms, Psychological symptoms, The TIME model

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Research centre for Age-related Functional decline and Disease (AFS) at Innlandet Hospital Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Home care services - Intervention group

Home care services - Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
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.
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
Transferring to nursing home
To measure the number of patients transferring to nursing home during follow up.
Minimal data set (MDS): patient rejection of care
The change in the patients rejection of care assessed by MDS: Minimal dataset (MDS)

Full Information

First Posted
July 24, 2019
Last Updated
September 28, 2020
Sponsor
Sykehuset Innlandet HF
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1. Study Identification

Unique Protocol Identification Number
NCT04034680
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
June 15, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sykehuset Innlandet HF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Behavioral symptoms, Dementia, Nevropsychiatric symptoms, Psychological symptoms, The TIME model

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomized trial
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home care services - Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Home care services - Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
TIME
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Education-only intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Affective symptoms measured by the Cornell Scale for Depression in Dementia (CSDD)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Neuropsychiatric Inventory - nursing home version (NPI-NH): Sub syndrome anxiety and depression
Description
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.
Time Frame
6 months
Title
NPI-NH: all separate items
Description
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.
Time Frame
6 months
Title
NPI-NH: caregiver distress score
Description
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
Time Frame
6 months
Title
Quality of life measured by the scale QUALID
Description
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.
Time Frame
6 months
Title
Change in Relatives Stress scale Score (RSS)
Description
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
Time Frame
6 months
Title
Transferring to nursing home
Description
To measure the number of patients transferring to nursing home during follow up.
Time Frame
12 months
Title
Minimal data set (MDS): patient rejection of care
Description
The change in the patients rejection of care assessed by MDS: Minimal dataset (MDS)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sverre Bergh, PhD
Organizational Affiliation
The Research centre for Age-related Functional decline and Disease (AFS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Research centre for Age-related Functional decline and Disease (AFS) at Innlandet Hospital Trust
City
Ottestad
ZIP/Postal Code
2312
Country
Norway

12. IPD Sharing Statement

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

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