DementiaPRESTANCT03732521
Management of Psychological and Behavioral Symptoms in Patients With Dementias
A study testing Educational therapy in people with Dementia and Family Relations, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dementia, Family Relations, Psychological and Behavioral Symptoms
- What is being tested?
- Educational therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 10 Feb 2014to 5 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Being tested
- Educational therapy
- Keywords
- Dementia, family caregiver, Zarit scale, NPI-10, psychological and behavioral symptoms
- Medical subject headings
- Dementia, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational therapyOther
educational intervention to the caregiver and individualization according to their family and social context
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | educational therapy Receives: Other: Educational therapy |
| Control group | No intervention | usual clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Activity Survey (Zarit scale) measures caregiver overload.
Change from baseline Zarit scale at 3 months. To assess caregiver burden we use the Zarit scale (Caregiver Overload Scale), validated in our setting and widely used not only in studies of dependency, but also in other populations. It consists of 22 questions with 5 possible answers (never, rarely, sometimes, quite often, quite often, almost always), scored from 1 to 5, and with a range of 22 to 110 in the total score, and which establishes the different degrees of overload according to the score obtained: absence of overload (≤ 46), light overload (47-55) and intense overload (≥ 56). The main drawback to its use is the size and, therefore, the time involved in its use.
Measured: At the beginning of the enrolment and 3 months later.
Neuropsychiatric Inventory (NPI).
Change from baseline of the NPI-10. The Neuropsychiatric Inventory (NPI) 10 items, is a relatively brief interview with a family member or friend who knows the patient well and can evaluate 12 behavioral areas commonly affected in patients with dementia, including depression. It is also routinely used to evaluate the effects of treatment on these symptoms. The total severity score on the NPI-10 represents the sum of the individual symptom scores and ranges from 0 to 36 . Caregiver distress associated with the symptom is scored on a 0- to 5-point anchored scale identical to that used in the NPI.
Measured: At the beginning of the enrolment and 3 months later.
Secondary outcomes (1)
Sociodemographic measures.
Gender (man and woman), Age (years) and Employment status (acoccupationally active or inactive).
Measured: At the beginning of the enrolment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start10 Feb 2014
- Primary completion20 Nov 2016
- Study completion5 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732521
- Sponsor's protocol ID
- CEIC-10/2014
- Acronym
- PRESTA
- Status last verified
- Feb 2024
- First submitted
- 5 Oct 2018
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03732521
- Acronym / sponsor ID
- PRESTA / CEIC-10/2014
- Keywords
- Dementia, family caregiver, Zarit scale, NPI-10, psychological and behavioral symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- Study start
- 10 Feb 2014 (actual)
- Primary completion
- 20 Nov 2016 (actual)
- Study completion
- 5 Sep 2017 (actual)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Educational therapyeducational therapy |
| Control group | No intervention | –usual clinical practice |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational therapyeducational intervention to the caregiver and individualization according to their family and social context | Other | Intervention group |
Primary outcome
Caregiver Activity Survey (Zarit scale) measures caregiver overload.
Time frame: At the beginning of the enrolment and 3 months later.
Change from baseline Zarit scale at 3 months. To assess caregiver burden we use the Zarit scale (Caregiver Overload Scale), validated in our setting and widely used not only in studies of dependency, but also in other populations. It consists of 22 questions with 5 possible answers (never, rarely, sometimes, quite often, quite often, almost always), scored from 1 to 5, and with a range of 22 to 110 in the total score, and which establishes the different degrees of overload according to the score obtained: absence of overload (≤ 46), light overload (47-55) and intense overload (≥ 56). The main drawback to its use is the size and, therefore, the time involved in its use.
Neuropsychiatric Inventory (NPI).
Time frame: At the beginning of the enrolment and 3 months later.
Change from baseline of the NPI-10. The Neuropsychiatric Inventory (NPI) 10 items, is a relatively brief interview with a family member or friend who knows the patient well and can evaluate 12 behavioral areas commonly affected in patients with dementia, including depression. It is also routinely used to evaluate the effects of treatment on these symptoms. The total severity score on the NPI-10 represents the sum of the individual symptom scores and ranges from 0 to 36 . Caregiver distress associated with the symptom is scored on a 0- to 5-point anchored scale identical to that used in the NPI.
1 secondary outcome
Sociodemographic measures.
Time frame: At the beginning of the enrolment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational therapy in people with Dementia and Family Relations, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Activity Survey (Zarit scale) measures caregiver overload. (time frame: At the beginning of the enrolment and 3 months later.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.