NCT03057184

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 ADCC, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

February 12, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

10 months

First QC Date

February 12, 2017

Last Update Submit

November 13, 2022

Conditions

Keywords

Adult Day Care Centerbehavioral problemscaregivers

Outcome Measures

Primary Outcomes (1)

  • disruptive behaviors

    Measured by the questionary disruptive behaviors will be measured with RMBPC

    Post intervention (6 months follow-up assessment will be performed)

Study Arms (2)

Intervention group

EXPERIMENTAL

behavioral intervention program

Behavioral: Intervention

Usual care

NO INTERVENTION

Usual care

Interventions

InterventionBEHAVIORAL

The intervention will consist of 8 weekly sessions, with a duration of 90 minutes. Although each intervention is adapted to the specific behavioral problems

Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • 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;
  • Family caregivers recognize the existence of at least one BPSD associated with ADCC care;
  • Signature of informed consent by family caregivers.

You may not qualify if:

  • Paid caregivers;
  • Family caregivers who do not participate in the preparation for the ADCC visit;
  • Those who do not sign informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundacion INFOSALUD

Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Problem Behavior

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorChild Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Luis Garcia Ortiz, MD

    Instituto de Investigación Biomédica de Salamanca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: It is an experimental design using random assignment to select 130 family members responsible for the preparation and transfer of the care-recipient from their home to the ADCC: was randomized to an intervention group or control group (care as usual).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2017

First Posted

February 17, 2017

Study Start

February 12, 2017

Primary Completion

December 12, 2017

Study Completion

December 31, 2018

Last Updated

November 16, 2022

Record last verified: 2022-11

Locations