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Clinical Trials/NCT05977855
NCT05977855
Recruiting
Not Applicable

Use of a Diary to Assess and Monitor Behavioral and Psychological Symptoms of Dementia

Fondazione IRCCS San Gerardo dei Tintori9 sites in 1 country300 target enrollmentJuly 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Behavioral and Psychiatric Symptoms of Dementia
Sponsor
Fondazione IRCCS San Gerardo dei Tintori
Enrollment
300
Locations
9
Primary Endpoint
Zarit Burden Interview
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The goal of this randomized clinical trial is to compare the efficacy of the use of a diary to record behavioral and psychological symptoms of dementia (BPSD) in persons with dementia. The main questions it aims to answer are:

  • Does the use of a diary lead to a reduction of the caregiver's burden at 3 months, compared with standard care?
  • Does the use of a diary lead to a reduction of the neuropsychiatric inventory (NPI) score at 3 months, compared with standard care?
  • Does the use of a diary result in less psychotropic drugs prescribed to the patient at 3 months compared with standard care?
  • Are physicians and caregivers satisfied with managing patients with the use of a diary?
  • Does the use of a diary reduce the caregiver's stress related to BPSD at 3 months, compared with standard care? Participants will be randomly assigned to either the use of a diary or a control group. Caregivers in the diary arm will be asked to fill in a diary with BPSD including triggers, severity, day and hour, to be analyzed by physicians to prescribe appropriate pharmacological or non-pharmacological interventions. The control group will receive usual care (i.e., appropriate interventions will be applied after interviewing the caregiver and/or visiting the patient).
Registry
clinicaltrials.gov
Start Date
July 1, 2023
End Date
July 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fondazione IRCCS San Gerardo dei Tintori
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of cognitive impairment (neurodegenerative or vascular)
  • Caregiver and patient willing to participate in the study
  • Caregiver living with the patient or able to cover all 24 hours
  • Presence of BPSD pertaining to the hyperactivity-irritability-impulsivity-disinhibition cluster (HIDA)
  • Signed informed consent before the beginning of the study

Exclusion Criteria

  • Refusal to consent to participate in the study

Outcomes

Primary Outcomes

Zarit Burden Interview

Time Frame: 3 months

Zarit Burden Interview difference between intervention arm and controls

Secondary Outcomes

  • Olanzapine equivalents(3 months)
  • Neuropsychiatric Inventory(3 months)
  • Neuropsychiatric Inventory - Caregiver Distress Scale(3 months)
  • Satisfaction questionnaire(3 months)

Study Sites (9)

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