Caregiver Training: Evidence of Its Effectiveness for Cognitive and Functional Improvement in Older Adults
Primary Purpose
Functional Ability, Cognitive Decline, Older Adults
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cognitive Stimulation
Sponsored by

About this trial
This is an interventional treatment trial for Functional Ability focused on measuring Older adults, Caregiver training program, Cognitive stimulation, Professional caregivers, Family caregivers
Eligibility Criteria
Inclusion Criteria:
- Older adults: age 65 or older, receiving care, no diagnosis of dementia, and their informed consent.
Exclusion Criteria:
-
Sites / Locations
- Centro Residencial de Mayores "Entreálamos"
- Unidad de Estancia Diurna de Atarfe
- Residencia de mayores María Zayas
- Centro Residencial Regina Mundi
- Centro Residencial Geriatric XXI
- Unidad de Estancia Diurna Ogíjares
- Unidad de Estancia Diurna Dr. Alejandro Otero
- Centro Cívico Zaidín del Ayuntamiento de Granada
- Centro Cívico Genil del Ayuntamiento de Granada
- University of Granada
Outcomes
Primary Outcome Measures
Mini-Examen-Cognoscitivo (MEC), Spanish adaptation of the Mini-Mental-State-Examination (MMSE).
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).
The Procedimiento de Evaluación Clifton para Ancianos - Cognitive Scale, a Spanish adaptation of the Clifton Assessment Procedure for the Elderly (CAPE).
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.
EuroQol
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.
Barthel Index
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.
Revised Memory and Behavior Problem Checklist (RMBPC), in its Spanish version.
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.
Positive Aspects of Caregiving (PAC).
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04490070
Brief Title
Caregiver Training: Evidence of Its Effectiveness for Cognitive and Functional Improvement in Older Adults
Official Title
Caregiver Training: Evidence of Its Effectiveness for Cognitive and Functional Improvement in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 10, 2015 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
March 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Ability, Cognitive Decline, Older Adults, Healthy Aging
Keywords
Older adults, Caregiver training program, Cognitive stimulation, Professional caregivers, Family caregivers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Stimulation
Intervention 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.
Primary Outcome Measure Information:
Title
Mini-Examen-Cognoscitivo (MEC), Spanish adaptation of the Mini-Mental-State-Examination (MMSE).
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).
Time Frame
9 months
Title
The Procedimiento de Evaluación Clifton para Ancianos - Cognitive Scale, a Spanish adaptation of the Clifton Assessment Procedure for the Elderly (CAPE).
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.
Time Frame
9 months
Title
EuroQol
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.
Time Frame
9 months
Title
Barthel Index
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.
Time Frame
9 months
Title
Revised Memory and Behavior Problem Checklist (RMBPC), in its Spanish version.
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.
Time Frame
9 months
Title
Positive Aspects of Caregiving (PAC).
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).
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Older adults: age 65 or older, receiving care, no diagnosis of dementia, and their informed consent.
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Navarro
Organizational Affiliation
Universidad de Granada
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dolores Calero
Organizational Affiliation
Universidad de Granada
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Miriam Sanjuán
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Residencial de Mayores "Entreálamos"
City
Atarfe
State/Province
Granada
ZIP/Postal Code
18230
Country
Spain
Facility Name
Unidad de Estancia Diurna de Atarfe
City
Atarfe
State/Province
Granada
ZIP/Postal Code
18230
Country
Spain
Facility Name
Residencia de mayores María Zayas
City
Belicena
State/Province
Granada
ZIP/Postal Code
18101
Country
Spain
Facility Name
Centro Residencial Regina Mundi
City
Churriana de la Vega
State/Province
Granada
ZIP/Postal Code
18194
Country
Spain
Facility Name
Centro Residencial Geriatric XXI
City
Cúllar Vega
State/Province
Granada
ZIP/Postal Code
18195
Country
Spain
Facility Name
Unidad de Estancia Diurna Ogíjares
City
Ogíjares
State/Province
Granada
ZIP/Postal Code
18151
Country
Spain
Facility Name
Unidad de Estancia Diurna Dr. Alejandro Otero
City
Pulianas
State/Province
Granada
ZIP/Postal Code
18197
Country
Spain
Facility Name
Centro Cívico Zaidín del Ayuntamiento de Granada
City
Granada
ZIP/Postal Code
18007
Country
Spain
Facility Name
Centro Cívico Genil del Ayuntamiento de Granada
City
Granada
ZIP/Postal Code
18008
Country
Spain
Facility Name
University of Granada
City
Granada
ZIP/Postal Code
18011
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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Caregiver Training: Evidence of Its Effectiveness for Cognitive and Functional Improvement in Older Adults
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