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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.
 
ClinicalTrials.gov Identifier: NCT03732521
Recruitment Status : Completed
First Posted : November 6, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Investigacio Sanitaria Pere Virgili

Tracking Information
First Submitted Date  ICMJE October 5, 2018
First Posted Date  ICMJE November 6, 2018
Last Update Posted Date November 6, 2018
Actual Study Start Date  ICMJE February 10, 2014
Actual Primary Completion Date November 20, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2018)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2018)
Sociodemographic measures [ Time Frame: At the beginning of the enrolment ]
Gender (man and woman), Age (years) and Employment status (acoccupationally active or inactive.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Management of Psychological and Behavioral Symptoms in Patients With Dementias
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Dementia
  • Family Relations
  • Psychological and Behavioral Symptoms
Intervention  ICMJE Other: Educational therapy
educational intervention to the caregiver and individualization according to their family and social context
Study Arms  ICMJE
  • Experimental: Intervention group
    educational therapy
    Intervention: Other: Educational therapy
  • No Intervention: Control group
    usual clinical practice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2018)
36
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 5, 2017
Actual Primary Completion Date November 20, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03732521
Other Study ID Numbers  ICMJE CEIC-10/2014
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut Investigacio Sanitaria Pere Virgili
Study Sponsor  ICMJE Institut Investigacio Sanitaria Pere Virgili
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institut Investigacio Sanitaria Pere Virgili
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP