Management of Psychological and Behavioral Symptoms in Patients With Dementias

Dementia Clinical Trial

— PRESTA  

Official title:

Clinical, Randomized and Double-blind Controlled Trial of an Educational Therapeutic Intervention for Family Caregivers on the Psychological and Behavioral Symptoms of Dementias (PRESTA Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03732521
• Other study ID #: CEIC-10/2014
• Status: Completed
• Phase: N/A
• Start date: February 10, 2014
• Est. completion date: September 5, 2017

Study information

• Verified date: February 2024
• Source: Institut Investigacio Sanitaria Pere Virgili
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A descriptive analysis of the sociodemographic characteristics of the intervention and control groups was done. Qualitative variables were expressed as percentages, and quantitative variables were summarised as the median and interquartile range. Shapiro-Wilk tests indicated that the dependent variables were not normally distributed (p < .05), so non-parametric statistical analyses were subsequently performed. The difference between the medians of the two patient groups was examined with the Mann-Whitney U test. Qualitative variables were compared with the chi-squared or Fisher's exact test, as appropriate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 5, 2017
• Est. primary completion date: November 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Behavioral Symptoms
• Dementia
• Family Relations
• Psychological and Behavioral Symptoms

Intervention

Other:
• Educational therapy
educational intervention to the caregiver and individualization according to their family and social context

Locations

Country	Name	City	State
Spain	Calamanda Matamoros	Tortosa	Tarragona

Sponsors (1)

Lead Sponsor	Collaborator
Institut Investigacio Sanitaria Pere Virgili

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Sociodemographic measures.	Gender (man and woman), Age (years) and Employment status (acoccupationally active or inactive).	At the beginning of the enrolment.