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Behavioral Problems Related to Attendance Adult Day Care Centers (PROCENDIAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03057184
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : February 20, 2020
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Information provided by (Responsible Party):
Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Brief Summary:
Adult Day Care Centers (ADCC) offer important relief and rest services for family caregivers. However, some caregivers report that behavioral and psychological symptoms of dementia (BPSD) arise when they prepare dependents for the ADC, especially when they have dementia. This issue increases stress for caregivers and contributes to a worsening of their mental health and quality of life. The present study evaluates the effectiveness of a behavioral intervention program aimed at reducing the reluctance of the dependent to attend the ADCC. We hope that reducing resistance will have a positive influence on the mental health of caregivers.

Condition or disease Intervention/treatment Phase
Family Members Dependence Behavioral: Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: It is an experimental design using random assignment to select 120 family members responsible for the preparation and transfer of the care-recipient from their home to the ADCC: will be randomized to an intervention group or control group (care as usual)..
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Behavioral Intervention to Reduce Resistance in Those Attending Adult Day Care Centers: PROCENDIAS Study. A Randomized Clinical Trial
Actual Study Start Date : February 12, 2017
Actual Primary Completion Date : December 12, 2017
Actual Study Completion Date : December 31, 2018

Arm Intervention/treatment
Experimental: Intervention group
behavioral intervention program
Behavioral: Intervention
The intervention will consist of 8 weekly sessions, with a duration of 90 minutes. Although each intervention is adapted to the specific behavioral problems

No Intervention: Usual care
Usual care

Primary Outcome Measures :
  1. disruptive behaviors [ Time Frame: Post intervention (6 months follow-up assessment will be performed) ]
    Measured by the questionary disruptive behaviors will be measured with RMBPC

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03057184

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Salamanca, Spain, 37007
Sponsors and Collaborators
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
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Study Director: Luis Garcia Ortiz, MD IBSAL
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Responsible Party: Fundacion para la Investigacion y Formacion en Ciencias de la Salud Identifier: NCT03057184    
Other Study ID Numbers: GRS1274/B/16
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundacion para la Investigacion y Formacion en Ciencias de la Salud:
Adult Day Care Center
behavioral problems
Additional relevant MeSH terms:
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Problem Behavior
Behavioral Symptoms