Caregiver Training: Evidence of Its Effectiveness for Cognitive and Functional Improvement in Older Adults

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 65 years and older
• All sexes
• No healthy volunteers
• Older adult

Trial locations and contacts

10 sites in 1 country.

About this study

Conditions

Functional Ability, Cognitive Decline, Older Adults, Healthy Aging

Being tested

Cognitive Stimulation

Keywords

Older adults, Caregiver training program, Cognitive stimulation, Professional caregivers, Family caregivers

Medical subject headings

Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Cognitive StimulationBehavioural

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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).

   Measured: 9 months

2. 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.

   Measured: 9 months

3. 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.

   Measured: 9 months

4. 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.

   Measured: 9 months

5. 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.

   Measured: 9 months

6. 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).

   Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted28 Jul 2020
2. Study start10 Dec 2015
3. Primary completion10 Mar 2020
4. Study completion10 Mar 2020

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Functional AbilityStudies 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.