World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 21 November 2022
Main ID:  NCT03057184
Date of registration: 12/02/2017
Prospective Registration: Yes
Primary sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Public title: Behavioral Problems Related to Attendance Adult Day Care Centers PROCENDIAS
Scientific title: Behavioral Intervention to Reduce Resistance in Those Attending Adult Day Care Centers: PROCENDIAS Study. A Randomized Clinical Trial
Date of first enrolment: February 12, 2017
Target sample size: 120
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03057184
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Care Provider).  
Phase:  N/A
Countries of recruitment
Spain
Contacts
Name:     Luis Garcia Ortiz, MD
Address: 
Telephone:
Email:
Affiliation:  IBSAL
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Participants in the study are those family members who help in the care of the person
attending the ADCC at least two days a week;

2. Family caregivers perform or participate in organizing the dependent patient's
preparation to visit the ADCC, with or without the help of another person. It is
define "preparation for attendance" as all the activities performed by the caregivers
in interaction with the patient, from the moment in which they begin to prepare until
they get into the vehicle taking them to the ADCC, with the aim of facilitating their
ADCC attendance. This includes, for example, waking them up, getting them out of bed,
helping them shower and get dressed, assisting them at breakfast, helping them to walk
and use the stairs, communicating with them about current actions and what they will
be doing in the immediate future;

3. Family caregivers recognize the existence of at least one BPSD associated with ADCC
care;

4. Signature of informed consent by family caregivers.

Exclusion Criteria:

1. Paid caregivers;

2. Family caregivers who do not participate in the preparation for the ADCC visit;

3. Those who do not sign informed consent.



Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Dependence
Family Members
Intervention(s)
Behavioral: Intervention
Primary Outcome(s)
disruptive behaviors [Time Frame: Post intervention (6 months follow-up assessment will be performed)]
Secondary Outcome(s)
Secondary ID(s)
GRS1274/B/16
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history