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

• ClinicalTrials.gov Identifier: NCT03057184
• Recruitment Status: Completed
• First Posted: February 17, 2017
• Last Update Posted: February 20, 2020
• Sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
• Collaborator: 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

Study Description

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

Detailed Description:

Randomized controlled trial. The trial will be performed in accordance with the SPIRIT 2013 Statement. The protocol was registered in the Clinical Trials-gov (PROCENDIAS study). Information about the study protocol, including the objectives, procedures, possible benefits and risks will be provided at the beginning of the study and written informed consent, according to the general recommendations of the Declaration of Helsinki(31), will be obtained from each study participant.

Study Population:

The study will be conducted in the municipality of Salamanca based on a list of people who attend an ADCC and whose relatives agree to participate voluntarily in the study. The reference population will be people attending ADCC and the relatives who participate in their care and who identify themselves as principal caregivers for this task.

Variables and measurement instruments The data will be collected in an interview, using the questionnaire designed for the study.

1. Outcome variables:

   Behavioral problems. The frequency and distress associated with disruptive behaviors will be measured with the Spanish version of the disruptive behaviors sub-scale of the Revised Memory and Behavior Problems Checklist (RMBPC), an 8-item scale with answers ranging from 0 (never occurred) to 4 (occurs daily or more often), for the frequency score, and from 0 (not at all) to 4 (extremely), for the distress score.

   Likewise, the neuropsychiatric inventory (NPI) will also be used to assess behavioral problems. Caregivers' mental health as self-perceived by caregivers will be measured using the 12-item version of the GHQ-12. Depressive symptomatology will be measured through the Center for Epidemiologic Studies Depression Scale (CES-D), a 20-item scale .Anxiety will be assessed using the Tension Subscale from the Profile of Mood States (POMS; McNair & et al., 1971),

2. Sociodemographic information and secondary measures:
3. ADCC Users: Sociodemographic variables: age, gender, marital status and years of schooling. Neuropsychological and clinical variables: cognitive status (MMSE; Reisberg's Global Deterioration Scale (GDS); comorbidity (Charlson's comorbidity index). Functional capacity: basic activities of daily life (Barthel index); instrumental activities of daily living (Lawton-Brody index);
4. ADCC staff: Sociodemographic variables of ADCC professionals; Perception of BPSD among transport service staff: Questionnaire on problems and perception of BPSD among transport service staff created ad hoc for the present study.

Baseline Evaluation and Follow-Up:

All ADCCs in the city will be invited to participate. Those centers agreeing to participate in the study will send an information letter about the project to the home of each of their users inviting them to participate in the study. Those who accept will notify the ADCC, and the ADCC will refer them to the research group. After about 10-15 days the participants will receive a telephone call from the research team to arrange an appointment and conduct the first interview. Assessments will be done either at the ADCC or at the relevant health center. After carrying out an initial assessment of the relatives who agreed to participate, those who meet the study's inclusion criteria will be selected. It will be confirmed to the Principal Investigator that the initial information is complete and the caregiver will be assigned to the corresponding group (intervention (IG) or control (CG), 1:1) in accordance with a previously randomized sequence. Those selected for the IG will be invited to participate in the weekly sessions in different groups of six people each and offered two different days of the week and the possibility of participating in morning or afternoon slots. Participants in the intervention group will be divided into groups of six of different ages and gender. Similarly, caregivers of relatives with different pathologies are included. The assessment will be repeated six months from the baseline evaluation, in a follow-up assessment. All the evaluations will be repeated for both CG and IG groups in similar time points.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Spain

Fundacion INFOSALUD

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

Investigators

• Study Director: Luis Garcia Ortiz, MD; IBSAL

More Information

• Responsible Party: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
• ClinicalTrials.gov Identifier: NCT03057184
• Other Study ID Numbers: GRS1274/B/16
• First Posted: February 17, 2017
• Last Update Posted: February 20, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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; caregivers

Additional relevant MeSH terms:

Problem Behavior; Behavioral Symptoms