Clinical trial NCT03732521: Management of Psychological and Behavioral Symptoms in Patients With Dementias
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Family Relations
Psychological and Behavioral Symptoms
Keywords: Dementia
family caregiver
Zarit scale
NPI-10
psychological and behavioral symptoms
Lead sponsor: Institut Investigacio Sanitaria Pere Virgili
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Caregiver Activity Survey (Zarit scale) measures caregiver overload.
timeFrame: At the beginning of the enrolment and 3 months later.
measure: Neuropsychiatric Inventory (NPI).
timeFrame: At the beginning of the enrolment and 3 months later.
Secondary outcomes:
measure: Sociodemographic measures.
timeFrame: At the beginning of the enrolment.
Other outcomes:
Locations:
city: Tortosa
country: Spain
facility: Calamanda Matamoros
state: Tarragona
Study officials:
References: