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

Primary Purpose

Dementia, Family Relations, Psychological and Behavioral Symptoms

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Educational therapy

About this trial

This is an interventional other trial for Dementia focused on measuring Dementia, family caregiver, Zarit scale, NPI-10, psychological and behavioral symptoms

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Calamanda Matamoros

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

educational therapy

usual clinical practice

Outcomes

Primary Outcome Measures

Zarit scale of caregiver overload

Change from baseline Zarit scale at 3 months

Neuropsychiatric Inventory

Change from baselin of the NPI-10

Secondary Outcome Measures

Sociodemographic measures

Gender (man and woman), Age (years) and Employment status (acoccupationally active or inactive.

Full Information

NCT ID

NCT03732521

First Posted

October 5, 2018

Last Updated

November 5, 2018

Sponsor

Institut Investigacio Sanitaria Pere Virgili

1. Study Identification

Unique Protocol Identification Number

NCT03732521

Brief Title

Management of Psychological and Behavioral Symptoms in Patients With Dementias

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

February 10, 2014 (Actual)

Primary Completion Date

November 20, 2016 (Actual)

Study Completion Date

September 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Investigacio Sanitaria Pere Virgili

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dementia, Family Relations, Psychological and Behavioral Symptoms

Keywords

Dementia, family caregiver, Zarit scale, NPI-10, psychological and behavioral symptoms

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Experimental

Arm Description

educational therapy

Arm Title

Control group

Arm Type

No Intervention

Arm Description

usual clinical practice

Intervention Type

Other

Intervention Name(s)

Educational therapy

Intervention Description

educational intervention to the caregiver and individualization according to their family and social context

Primary Outcome Measure Information:

Title

Zarit scale of caregiver overload

Description

Change from baseline Zarit scale at 3 months

Time Frame

At the beginning of the enrolment and 3 months later

Title

Neuropsychiatric Inventory

Description

Change from baselin of the NPI-10

Time Frame

At the beginning of the enrolment and 3months later

Secondary Outcome Measure Information:

Title

Sociodemographic measures

Description

Gender (man and woman), Age (years) and Employment status (acoccupationally active or inactive.

Time Frame

At the beginning of the enrolment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Calamanda Matamoros

City

Tortosa

State/Province

Tarragona

ZIP/Postal Code

43500

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

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Management of Psychological and Behavioral Symptoms in Patients With Dementias

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