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Trial record 27 of 1046 for:    scale | Norway

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

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ClinicalTrials.gov Identifier: NCT04034680
Recruitment Status : Recruiting
First Posted : July 26, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Sykehuset Innlandet HF

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.

Condition or disease Intervention/treatment Phase
Dementia Other: TIME Other: Education-only intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomized trial
Masking: Single (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.
Primary Purpose: Treatment
Official Title: The TIME -Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms - for Continuity of Care in Home Care Services
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

Active Comparator: 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.
Other: 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.




Primary Outcome Measures :
  1. Affective symptoms measured by the Cornell Scale for Depression in Dementia (CSDD) [ Time Frame: 6 months ]
    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 :
  1. Neuropsychiatric Inventory - nursing home version (NPI-NH): Sub syndrome anxiety and depression [ Time Frame: 6 months ]
    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.

  2. NPI-NH: all separate items [ Time Frame: 6 months ]
    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.

  3. NPI-NH: caregiver distress score [ Time Frame: 6 months ]
    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

  4. Quality of life measured by the scale QUALID [ Time Frame: 6 months ]
    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.

  5. Change in Relatives Stress scale Score (RSS) [ Time Frame: 6 months ]
    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. Transferring to nursing home [ Time Frame: 12 months ]
    To measure the number of patients transferring to nursing home during follow up.

  7. Minimal data set (MDS): patient rejection of care [ Time Frame: 6 months ]
    The change in the patients rejection of care assessed by MDS: Minimal dataset (MDS)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04034680


Contacts
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Contact: Sverre Bergh, PhD +47 45679393 sverre.bergh@sykehuset-innlandet.no
Contact: Kari-Anne Hoel +47 97128559 kari-anne.hoel@sykehuset-innlandet.no

Locations
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Norway
The Research centre for Age-related Functional decline and Disease (AFS) at Innlandet Hospital Trust Recruiting
Ottestad, Norway, 2312
Contact: Sverre Bergh, PhD    +4745679393    sverre.bergh@sykehuset-innlandet.no   
Contact: Kari-Anne Hoel    +47 97128559    kari-anne.hoel@sykehuset-innlandet.no   
Sponsors and Collaborators
Sykehuset Innlandet HF
Investigators
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Principal Investigator: Sverre Bergh, PhD The Research centre for Age-related Functional decline and Disease (AFS)

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Responsible Party: Sykehuset Innlandet HF
ClinicalTrials.gov Identifier: NCT04034680     History of Changes
Other Study ID Numbers: SI0303150608
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sykehuset Innlandet HF:
Behavioral symptoms
Dementia
Nevropsychiatric symptoms
Psychological symptoms
The TIME model
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders