- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04490070
Caregiver Training: Evidence of Its Effectiveness for Cognitive and Functional Improvement in Older Adults
July 27, 2020 updated by: Miriam Sanjuan, Universidad de Granada
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).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Granada, Spain, 18011
- University of Granada
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Granada, Spain, 18007
- Centro Cívico Zaidín del Ayuntamiento de Granada
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Granada, Spain, 18008
- Centro Cívico Genil del Ayuntamiento de Granada
-
-
Granada
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Atarfe, Granada, Spain, 18230
- Centro Residencial de Mayores "Entreálamos"
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Atarfe, Granada, Spain, 18230
- Unidad de Estancia Diurna de Atarfe
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Belicena, Granada, Spain, 18101
- Residencia de mayores María Zayas
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Churriana de la Vega, Granada, Spain, 18194
- Centro Residencial Regina Mundi
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Cúllar Vega, Granada, Spain, 18195
- Centro Residencial Geriatric XXI
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Ogíjares, Granada, Spain, 18151
- Unidad de Estancia Diurna Ogíjares
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Pulianas, Granada, Spain, 18197
- Unidad de Estancia Diurna Dr. Alejandro Otero
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Older adults: age 65 or older, receiving care, no diagnosis of dementia, and their informed consent.
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mini-Examen-Cognoscitivo (MEC), Spanish adaptation of the Mini-Mental-State-Examination (MMSE).
Time Frame: 9 months
|
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).
|
9 months
|
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
|
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.
|
9 months
|
EuroQol
Time Frame: 9 months
|
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.
|
9 months
|
Barthel Index
Time Frame: 9 months
|
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.
|
9 months
|
Revised Memory and Behavior Problem Checklist (RMBPC), in its Spanish version.
Time Frame: 9 months
|
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.
|
9 months
|
Positive Aspects of Caregiving (PAC).
Time Frame: 9 months
|
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).
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Elena Navarro, Universidad de Granada
- Study Chair: Dolores Calero, Universidad de Granada
- Principal Investigator: Miriam Sanjuán, Universidad de Granada
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 10, 2015
Primary Completion (Actual)
March 10, 2020
Study Completion (Actual)
March 10, 2020
Study Registration Dates
First Submitted
July 23, 2020
First Submitted That Met QC Criteria
July 27, 2020
First Posted (Actual)
July 28, 2020
Study Record Updates
Last Update Posted (Actual)
July 28, 2020
Last Update Submitted That Met QC Criteria
July 27, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 545/CEIH/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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