Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 24, 2019
First Posted Date  ICMJE July 26, 2019
Last Update Posted Date July 31, 2019
Actual Study Start Date  ICMJE February 1, 2019
Estimated Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 24, 2019)
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).
Change History Complete list of historical versions of study NCT04034680 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2019)
  • 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.
  • 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.
  • 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
  • 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.
  • 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
  • Transferring to nursing home [ Time Frame: 12 months ]
    To measure the number of patients transferring to nursing home during follow up.
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2019)
  • 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.
  • NPI-NH: all separate items [ Time Frame: 6 months ]
    The change from baseline of the NPI-NH, scores on all the 12 items.
  • NPI-NH: caregiver distress score [ Time Frame: 6 months ]
    The change from baseline in caregiver distress by the NPI-NH caregiver distress score
  • 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 distress
  • 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
  • Transferring to nursing home [ Time Frame: 12 months ]
    To measure the patients transferring to nursing home
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms in Home Care Services
Official Title  ICMJE The TIME -Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms - for Continuity of Care in Home Care Services
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Dementia
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: TIME
  • 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.
    Intervention: Other: Education-only intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 24, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sverre Bergh, PhD +47 45679393 sverre.bergh@sykehuset-innlandet.no
Contact: Kari-Anne Hoel +47 97128559 kari-anne.hoel@sykehuset-innlandet.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04034680
Other Study ID Numbers  ICMJE SI0303150608
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sykehuset Innlandet HF
Study Sponsor  ICMJE Sykehuset Innlandet HF
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sverre Bergh, PhD The Research centre for Age-related Functional decline and Disease (AFS)
PRS Account Sykehuset Innlandet HF
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP