Management of Psychological and Behavioral Symptoms in Patients With Dementias (PRESTA)
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|ClinicalTrials.gov Identifier: NCT03732521|
Recruitment Status : Completed
First Posted : November 6, 2018
Last Update Posted : November 6, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Dementia Family Relations Psychological and Behavioral Symptoms||Other: Educational therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||February 10, 2014|
|Actual Primary Completion Date :||November 20, 2016|
|Actual Study Completion Date :||September 5, 2017|
Experimental: Intervention group
Other: Educational therapy
educational intervention to the caregiver and individualization according to their family and social context
No Intervention: Control group
usual clinical practice
- Zarit scale of caregiver overload [ Time Frame: At the beginning of the enrolment and 3 months later ]Change from baseline Zarit scale at 3 months
- Neuropsychiatric Inventory [ Time Frame: At the beginning of the enrolment and 3months later ]Change from baselin of the NPI-10
- Sociodemographic measures [ Time Frame: At the beginning of the enrolment ]Gender (man and woman), Age (years) and Employment status (acoccupationally active or inactive.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03732521
|Tortosa, Tarragona, Spain, 43500|