Management of Psychological and Behavioral Symptoms in Patients With Dementias

NCT03732521 | Completed

• 1 other identifier: CEIC-10/2014
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The psychological and behavioral symptoms (SPCD) of dementias are the manifestations that cause the most suffering in the patient and caregiver, worsening the other two symptomatic areas (cognitive and functional) and precipitating the early institutionalization of patients with dementia. non-pharmacological therapies (TNF) in dementia are framed in the biopsychosocial model of patient care. We found evidence in the literature about the effectiveness of ambulatory educational interventions to the family caregiver in terms of reducing overload and improving their state of mind But it is not well demonstrated whether this improvement can have an indirect impact on the SPCD of the patient, nor whether the profile of patients could have an added benefit to the best pharmacological treatment. Methods: The experimental study selected thirty-six older adults family caregivers of patients with dementia.The intervention group (n=18) received isolated medical treatment, while the control group (n=18) received medical treatment plus educational support therapy to their family caregivers. Data collection included sociodemographic measures and responses to the educational support therapy tot the Zarit Caregiver Overload Scale (family caregivers) and Neuropsychiatric Inventory (NPI-10) patients with dementia.

Conditions

Dementia; Family Relations; Psychological and Behavioral Symptoms

Keywords

Dementia; family caregiver; Zarit scale; NPI-10; psychological and behavioral symptoms

Outcome Measures

Primary Outcomes (2)

• Caregiver Activity Survey (Zarit scale) measures caregiver overload.

  Change from baseline Zarit scale at 3 months. To assess caregiver burden we use the Zarit scale (Caregiver Overload Scale), validated in our setting and widely used not only in studies of dependency, but also in other populations. It consists of 22 questions with 5 possible answers (never, rarely, sometimes, quite often, quite often, almost always), scored from 1 to 5, and with a range of 22 to 110 in the total score, and which establishes the different degrees of overload according to the score obtained: absence of overload (≤ 46), light overload (47-55) and intense overload (≥ 56). The main drawback to its use is the size and, therefore, the time involved in its use.

  At the beginning of the enrolment and 3 months later.

• Neuropsychiatric Inventory (NPI).

  Change from baseline of the NPI-10. The Neuropsychiatric Inventory (NPI) 10 items, is a relatively brief interview with a family member or friend who knows the patient well and can evaluate 12 behavioral areas commonly affected in patients with dementia, including depression. It is also routinely used to evaluate the effects of treatment on these symptoms. The total severity score on the NPI-10 represents the sum of the individual symptom scores and ranges from 0 to 36 . Caregiver distress associated with the symptom is scored on a 0- to 5-point anchored scale identical to that used in the NPI.

  At the beginning of the enrolment and 3 months later.

Secondary Outcomes (1)

• Sociodemographic measures.

  At the beginning of the enrolment.

Study Arms (2)

Intervention group

EXPERIMENTAL

educational therapy

Other: Educational therapy

Control group

NO INTERVENTION

usual clinical practice

Interventions

Educational therapy OTHER

educational intervention to the caregiver and individualization according to their family and social context

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of at least 6 months of dementia and on treatment with IACEs ± memantine.
• Patients diagnosed with dementia, who score on the global scale of Severity of Reisberg between 4 and 6, both included.
• Patients who at least obtain a score ≥ 4 on the NPI scale, version validated in Spanish. The symptoms must be present at least one month prior to the visit and will not be attributable to intercurrent medical pathology or to acute confusional syndrome.
• Patients living in a family home, and accompanied by a family caregiver who agrees to sign the informed consent after obtaining all the information of the study in question.

You may not qualify if:

• Patients with a diagnosis of mild cognitive impairment or who do not take specific medication (IACEs and / or memantine).
• Patients with severe sensory deprivation that does not allow MMSE scale assessment.
• Patients who present intercurrent medical illnesses that confers a poor short-term vital prognosis (6 months).
• Patients in which the SPCD may be in the context of a toxicometabolic disease, uncontrolled pain or delirium, according to the researcher's clinical criteria.
• Patients who are taking typical neuroleptics, long-acting BZD, major opioids or drugs that can potentially alter the state of consciousness.

Sponsors & Collaborators

• Institut Investigacio Sanitaria Pere Virgili: lead

Study Sites (1)

Calamanda Matamoros

Tortosa, Tarragona, 43500, Spain

Location

MeSH Terms

Conditions

Dementia; Behavioral Symptoms

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: November 6, 2018
• Study Start: February 10, 2014
• Primary Completion: November 20, 2016
• Study Completion: September 5, 2017
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)