<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04490070</url>
  </required_header>
  <id_info>
    <org_study_id>545/CEIH/2018</org_study_id>
    <nct_id>NCT04490070</nct_id>
  </id_info>
  <brief_title>Caregiver Training: Evidence of Its Effectiveness for Cognitive and Functional Improvement in Older Adults</brief_title>
  <official_title>Caregiver Training: Evidence of Its Effectiveness for Cognitive and Functional Improvement in Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Granada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Granada</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Due to demographic changes that have resulted in an aging population, the role of caregiver&#xD;
      of an older adult has become very important in recent years. While numerous programs have&#xD;
      been designed to lighten the caregiver's physical and emotional burden, fewer programs train&#xD;
      caregivers to improve skills and level of independence in the person they care for. The&#xD;
      objectives of this research study were to assess the benefits of a caregiver training program&#xD;
      on the cognitive and functional status of older adults, as well as to compare the effects of&#xD;
      this program according to type of caregiver (professional caregiver vs. family caregiver).&#xD;
      Methods: The sample was composed of 160 older adults: a) 100 received care from caregivers&#xD;
      who had taken the training program (treatment group), of which 60 were professional&#xD;
      caregivers and 40 were family caregivers; and b) 60 received care from caregivers who had not&#xD;
      taken the program (control group). In order to evaluate program effects on cognitive and&#xD;
      functional status, we used both direct measures (MMSE, CAPE and EuroQol) and caregiver&#xD;
      reports (Barthel and RMPBC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 10, 2015</start_date>
  <completion_date type="Actual">March 10, 2020</completion_date>
  <primary_completion_date type="Actual">March 10, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mini-Examen-Cognoscitivo (MEC), Spanish adaptation of the Mini-Mental-State-Examination (MMSE).</measure>
    <time_frame>9 months</time_frame>
    <description>This screening instrument is widely used for detecting cognitive impairment. The final score ranges from 0 to 35 points and is often used as a global index and method for monitoring the evolution of cognitive functions in cognitive impairment and dementia. It has high internal consistency (α = 0.88), good test-retest reliability (0.64-1.00; p &lt; 0.01) and good interjudge reliability (0.69-1.00; p &lt; 0.01).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Procedimiento de Evaluación Clifton para Ancianos - Cognitive Scale, a Spanish adaptation of the Clifton Assessment Procedure for the Elderly (CAPE).</measure>
    <time_frame>9 months</time_frame>
    <description>In the present study, we used the cognitive assessment scale only, which includes one part on information and orientation and another part on mental ability. The final score ranges from 0 to 23 points and higher scores mean a better outcome. Its test-retest reliability falls between 0.79 and 0.90, and between 0.61 and 0.69, for the information and orientation scale and for the mental ability scale, respectively.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>EuroQol</measure>
    <time_frame>9 months</time_frame>
    <description>Generic measure of health-related quality of life. The individual rates his or her own state of health, first rating levels of severity by dimensions, and afterward a more general assessment using a 20-centimeter visual analog scale (VAS) that goes from 0 to 100. Scores range from 0 to 2 on each of the test scales, and higher scores mean a worse result.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Barthel Index</measure>
    <time_frame>9 months</time_frame>
    <description>Evaluates the person's functional ability based on 10 items answered by the caregiver. Scores range from 0 to 100, with 0 being completely dependent and 100 completely independent. Its internal consistency presents an alpha coefficient between 0.86 and 0.92 and interjudge reliability between 0.84 and 0.97.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Revised Memory and Behavior Problem Checklist (RMBPC), in its Spanish version.</measure>
    <time_frame>9 months</time_frame>
    <description>Evaluates problems in memory, behavior, and anxiety and depression. The caregiver indicates how often the person under her care has manifest each of the problems described during the past week (frequency scale) and the degree that this bothers or worries her (reaction scale). An alpha coefficient of 0.84 was found for the frequency scale, and 0.90 for the reaction scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive Aspects of Caregiving (PAC).</measure>
    <time_frame>9 months</time_frame>
    <description>This 9-item instrument measures caregivers' satisfaction with providing care to the older adults. It consists of a 5-point Likert scale from 1 (disagree) to 5 (agree). Scores range from 9 to 45; higher scores indicate a more positive perception and gains from the caregiver experience. It presents good general reliability (Cronbach α = .89) and convergent validity (Cronbach α = .72).</description>
  </primary_outcome>
  <enrollment type="Actual">160</enrollment>
  <condition>Functional Ability</condition>
  <condition>Cognitive Decline</condition>
  <condition>Older Adults</condition>
  <condition>Healthy Aging</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Stimulation</intervention_name>
    <description>The caregiver training program consisted of applying the cognitive stimulation model of the CUIDA-2 program. This application included theoretical training made up of three modules: 1) person-centered care, 2) communication strategies, and 3) mediated cognitive stimulation strategies. The training was given in two group sessions of two hours each, plus 50 hours of individual practice, either on the job (in the case of professional caregivers) or in the home (in the case of family caregivers), in both cases supervised by psychologists who were experts in the program. In these individual practice hours, the caregivers were required to keep a weekly log. Here they had to plan in advance the activities that they were going to carry out with the older adult, and once they had taken place, they had to record how they were done and how the older adult had responded.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Older adults: age 65 or older, receiving care, no diagnosis of dementia, and their&#xD;
             informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elena Navarro</last_name>
    <role>Study Director</role>
    <affiliation>Universidad de Granada</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dolores Calero</last_name>
    <role>Study Chair</role>
    <affiliation>Universidad de Granada</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Miriam Sanjuán</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad de Granada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro Residencial de Mayores &quot;Entreálamos&quot;</name>
      <address>
        <city>Atarfe</city>
        <state>Granada</state>
        <zip>18230</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidad de Estancia Diurna de Atarfe</name>
      <address>
        <city>Atarfe</city>
        <state>Granada</state>
        <zip>18230</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Residencia de mayores María Zayas</name>
      <address>
        <city>Belicena</city>
        <state>Granada</state>
        <zip>18101</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Residencial Regina Mundi</name>
      <address>
        <city>Churriana de la Vega</city>
        <state>Granada</state>
        <zip>18194</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Residencial Geriatric XXI</name>
      <address>
        <city>Cúllar Vega</city>
        <state>Granada</state>
        <zip>18195</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidad de Estancia Diurna Ogíjares</name>
      <address>
        <city>Ogíjares</city>
        <state>Granada</state>
        <zip>18151</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidad de Estancia Diurna Dr. Alejandro Otero</name>
      <address>
        <city>Pulianas</city>
        <state>Granada</state>
        <zip>18197</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Cívico Zaidín del Ayuntamiento de Granada</name>
      <address>
        <city>Granada</city>
        <zip>18007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Cívico Genil del Ayuntamiento de Granada</name>
      <address>
        <city>Granada</city>
        <zip>18008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Granada</name>
      <address>
        <city>Granada</city>
        <zip>18011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Granada</investigator_affiliation>
    <investigator_full_name>Miriam Sanjuan</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Older adults</keyword>
  <keyword>Caregiver training program</keyword>
  <keyword>Cognitive stimulation</keyword>
  <keyword>Professional caregivers</keyword>
  <keyword>Family caregivers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04490070
org study id: 545/CEIH/2018
nct id: NCT04490070
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Due to demographic changes that have resulted in an aging population, the role of caregiver
      of an older adult has become very important in recent years. While numerous programs have
      been designed to lighten the caregiver's physical and emotional burden, fewer programs train
      caregivers to improve skills and level of independence in the person they care for. The
      objectives of this research study were to assess the benefits of a caregiver training program
      on the cognitive and functional status of older adults, as well as to compare the effects of
      this program according to type of caregiver (professional caregiver vs. family caregiver).
      Methods: The sample was composed of 160 older adults: a) 100 received care from caregivers
      who had taken the training program (treatment group), of which 60 were professional
      caregivers and 40 were family caregivers; and b) 60 received care from caregivers who had not
      taken the program (control group). In order to evaluate program effects on cognitive and
      functional status, we used both direct measures (MMSE, CAPE and EuroQol) and caregiver
      reports (Barthel and RMPBC).
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mini-Examen-Cognoscitivo (MEC), Spanish adaptation of the Mini-Mental-State-Examination (MMSE).
time frame: 9 months
description: This screening instrument is widely used for detecting cognitive impairment. The final score ranges from 0 to 35 points and is often used as a global index and method for monitoring the evolution of cognitive functions in cognitive impairment and dementia. It has high internal consistency (α = 0.88), good test-retest reliability (0.64-1.00; p < 0.01) and good interjudge reliability (0.69-1.00; p < 0.01).
measure: The Procedimiento de Evaluación Clifton para Ancianos - Cognitive Scale, a Spanish adaptation of the Clifton Assessment Procedure for the Elderly (CAPE).
time frame: 9 months
description: In the present study, we used the cognitive assessment scale only, which includes one part on information and orientation and another part on mental ability. The final score ranges from 0 to 23 points and higher scores mean a better outcome. Its test-retest reliability falls between 0.79 and 0.90, and between 0.61 and 0.69, for the information and orientation scale and for the mental ability scale, respectively.
measure: EuroQol
time frame: 9 months
description: Generic measure of health-related quality of life. The individual rates his or her own state of health, first rating levels of severity by dimensions, and afterward a more general assessment using a 20-centimeter visual analog scale (VAS) that goes from 0 to 100. Scores range from 0 to 2 on each of the test scales, and higher scores mean a worse result.
measure: Barthel Index
time frame: 9 months
description: Evaluates the person's functional ability based on 10 items answered by the caregiver. Scores range from 0 to 100, with 0 being completely dependent and 100 completely independent. Its internal consistency presents an alpha coefficient between 0.86 and 0.92 and interjudge reliability between 0.84 and 0.97.
measure: Revised Memory and Behavior Problem Checklist (RMBPC), in its Spanish version.
time frame: 9 months
description: Evaluates problems in memory, behavior, and anxiety and depression. The caregiver indicates how often the person under her care has manifest each of the problems described during the past week (frequency scale) and the degree that this bothers or worries her (reaction scale). An alpha coefficient of 0.84 was found for the frequency scale, and 0.90 for the reaction scale.
measure: Positive Aspects of Caregiving (PAC).
time frame: 9 months
description: This 9-item instrument measures caregivers' satisfaction with providing care to the older adults. It consists of a 5-point Likert scale from 1 (disagree) to 5 (agree). Scores range from 9 to 45; higher scores indicate a more positive perception and gains from the caregiver experience. It presents good general reliability (Cronbach α = .89) and convergent validity (Cronbach α = .72).
intervention type: Behavioral
intervention name: Cognitive Stimulation
description: The caregiver training program consisted of applying the cognitive stimulation model of the CUIDA-2 program. This application included theoretical training made up of three modules: 1) person-centered care, 2) communication strategies, and 3) mediated cognitive stimulation strategies. The training was given in two group sessions of two hours each, plus 50 hours of individual practice, either on the job (in the case of professional caregivers) or in the home (in the case of family caregivers), in both cases supervised by psychologists who were experts in the program. In these individual practice hours, the caregivers were required to keep a weekly log. Here they had to plan in advance the activities that they were going to carry out with the older adult, and once they had taken place, they had to record how they were done and how the older adult had responded.
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Elena Navarro
role: Study Director
affiliation: Universidad de Granada
last name: Dolores Calero
role: Study Chair
affiliation: Universidad de Granada
last name: Miriam Sanjuán
role: Principal Investigator
affiliation: Universidad de Granada
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad de Granada
investigator full name: Miriam Sanjuan
investigator title: Principal Investigator
mesh term: Cognitive Dysfunction
sharing ipd: No