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Management of Psychological and Behavioral Symptoms in Patients With Dementias (PRESTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03732521
Recruitment Status : Completed
First Posted : November 6, 2018
Last Update Posted : November 6, 2018
Information provided by (Responsible Party):
Institut Investigacio Sanitaria Pere Virgili

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.

Condition or disease Intervention/treatment Phase
Dementia Family Relations Psychological and Behavioral Symptoms Other: Educational therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Experimental: Intervention group
educational therapy
Other: Educational therapy
educational intervention to the caregiver and individualization according to their family and social context

No Intervention: Control group
usual clinical practice

Primary Outcome Measures :
  1. 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

  2. Neuropsychiatric Inventory [ Time Frame: At the beginning of the enrolment and 3months later ]
    Change from baselin of the NPI-10

Secondary Outcome Measures :
  1. Sociodemographic measures [ Time Frame: At the beginning of the enrolment ]
    Gender (man and woman), Age (years) and Employment status (acoccupationally active or inactive.

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03732521

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Calamanda Matamoros
Tortosa, Tarragona, Spain, 43500
Sponsors and Collaborators
Institut Investigacio Sanitaria Pere Virgili

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Responsible Party: Institut Investigacio Sanitaria Pere Virgili Identifier: NCT03732521    
Other Study ID Numbers: CEIC-10/2014
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Investigacio Sanitaria Pere Virgili:
family caregiver
Zarit scale
psychological and behavioral symptoms
Additional relevant MeSH terms:
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Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders