Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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21 November 2022 |
Main ID: |
NCT03057184 |
Date of registration:
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12/02/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Behavioral Problems Related to Attendance Adult Day Care Centers
PROCENDIAS |
Scientific title:
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Behavioral Intervention to Reduce Resistance in Those Attending Adult Day Care Centers: PROCENDIAS Study. A Randomized Clinical Trial |
Date of first enrolment:
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February 12, 2017 |
Target sample size:
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120 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03057184 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Care Provider).
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Phase:
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N/A
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Countries of recruitment
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Spain
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Contacts
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Name:
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Luis Garcia Ortiz, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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IBSAL |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Dependence
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Family Members
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Intervention(s)
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Behavioral: Intervention
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Primary Outcome(s)
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disruptive behaviors
[Time Frame: Post intervention (6 months follow-up assessment will be performed)]
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Secondary ID(s)
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GRS1274/B/16
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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