search
Back to results

Intervention on Caregivers Caring for Patients Poststroke With Upper Limb Apraxia (CPA)

Primary Purpose

Performance Anxiety, Emotional Stress

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Program on specific prevention of health
Program on general prevention of health
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Performance Anxiety focused on measuring Caregivers, Apraxias, Stroke, Cerebral Stroke, Rehabilitation, Pragmatic Clinical Trials as Topic

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Having an habitual role of carer (informal or formal).
  • Being caring a mild-moderate poststroke patient with upper limb apraxia.
  • Subjective manifestations of overload in the role as carer.
  • More than two month as carer.

Exclusion Criteria:

  • Uncooperativeness
  • Being formed in the care of that kind of patients

Sites / Locations

  • University of Granada

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Program on specific prevention of health

Program on general prevention of health

Arm Description

The caregivers will be randomly assigned to an experimental group, to receive the program on specific prevention of health. The workshop will be performed twice a month, two hours a day, during a 4-week period.

Control group will receive an intervention by mean of a general health program to manage the common situations when a caregiver is caring for a patient with dependency. The workshop will be performed two a month, two hours a day, during a 4-week period.

Outcomes

Primary Outcome Measures

Change from Baseline in Stroke Impact Scale (SIS-16) at 8 weeks
Change from Baseline in Stroke Impact Scale (SIS-16) at 16 weeks

Secondary Outcome Measures

Change from Baseline in Barthel index at 8 weeks
Change from Baseline in Barthel index at 16 weeks
Change from Baseline in Disabilities of the Arm, Shoulder and Hand (Quick-DASH) at 8 weeks
Change from Baseline in Disabilities of the Arm, Shoulder and Hand (Quick-DASH) at 16 weeks
Change from Baseline in General health questionnaire (GHQ-28) at 8 weeks
Change from Baseline in General health questionnaire (GHQ-28) at 16 weeks
Change from Baseline in Zarit questionnaire at 8 weeks
Change from Baseline in Zarit questionnaire at 16 weeks
Change from Baseline in family APGAR at 8 weeks
Change from Baseline in family APGAR at 16 weeks
Change from Baseline in Duke-UNC-11 questionnaire of functional social support at 8 weeks
Change from Baseline in Duke-UNC-11 questionnaire of functional social support at 16 weeks

Full Information

First Posted
December 1, 2014
Last Updated
October 4, 2018
Sponsor
Universidad de Granada
search

1. Study Identification

Unique Protocol Identification Number
NCT02307019
Brief Title
Intervention on Caregivers Caring for Patients Poststroke With Upper Limb Apraxia
Acronym
CPA
Official Title
Intervention on Caregivers Caring for Patients Poststroke With Upper Limb Apraxia: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to analyze the effects of a intervention on a specific health prevention/intervention program aimed at caregivers of mild and moderate patients post stroke with upper limb apraxia in comparison to a control group with a no specific formation in that kind of patients.
Detailed Description
Patients with Upper limb apraxia after stroke have severe problems to adapt their daily life. The upper limb apraxia syndrome affects the performance of skilled movements carried out by the upper limbs and provoke that many patients´activities have to be made by their main caregiver or carers. Caregivers usually have to occupy much time and efforts for caring their familiar or client, and it can result in a overload in different areas of the caregiver health. Few data are available on the effectiveness of interventions in caregivers that informally works with that kind of patients. The specific prevention health program is based on improving the awareness of the assistance that the caregivers provide, and knowing the process of the information that carer has to give to the patient while the patients have their activities made.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Performance Anxiety, Emotional Stress
Keywords
Caregivers, Apraxias, Stroke, Cerebral Stroke, Rehabilitation, Pragmatic Clinical Trials as Topic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Program on specific prevention of health
Arm Type
Experimental
Arm Description
The caregivers will be randomly assigned to an experimental group, to receive the program on specific prevention of health. The workshop will be performed twice a month, two hours a day, during a 4-week period.
Arm Title
Program on general prevention of health
Arm Type
Active Comparator
Arm Description
Control group will receive an intervention by mean of a general health program to manage the common situations when a caregiver is caring for a patient with dependency. The workshop will be performed two a month, two hours a day, during a 4-week period.
Intervention Type
Other
Intervention Name(s)
Program on specific prevention of health
Other Intervention Name(s)
Program of specific intervention for caregivers
Intervention Description
The intervention will be centered in provide effective tools to manage each situation presented while a caregiver cares for patients poststroke with upper limb apraxia. Moreover, the workshops will be focused on the balance between the assistance provided by the caregiver and the improvement and the increase the autonomy and independence of the patients. Finally, we will provide skills and strategies to the caregiver for enhancing the environment adaptation of the patients.
Intervention Type
Other
Intervention Name(s)
Program on general prevention of health
Other Intervention Name(s)
Program on traditional intervention for caregivers
Intervention Description
The general health educative program will consist in an educational workshop for caregivers where they are taught the habitual guidelines to caring for patients in situation of dependency.
Primary Outcome Measure Information:
Title
Change from Baseline in Stroke Impact Scale (SIS-16) at 8 weeks
Time Frame
Eight weeks
Title
Change from Baseline in Stroke Impact Scale (SIS-16) at 16 weeks
Time Frame
Sixteen weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Barthel index at 8 weeks
Time Frame
Eight weeks
Title
Change from Baseline in Barthel index at 16 weeks
Time Frame
Sixteen weeks
Title
Change from Baseline in Disabilities of the Arm, Shoulder and Hand (Quick-DASH) at 8 weeks
Time Frame
Eight weeks
Title
Change from Baseline in Disabilities of the Arm, Shoulder and Hand (Quick-DASH) at 16 weeks
Time Frame
Sixteen weeks
Title
Change from Baseline in General health questionnaire (GHQ-28) at 8 weeks
Time Frame
Eight weeks
Title
Change from Baseline in General health questionnaire (GHQ-28) at 16 weeks
Time Frame
Sixteen weeks
Title
Change from Baseline in Zarit questionnaire at 8 weeks
Time Frame
Eight weeks
Title
Change from Baseline in Zarit questionnaire at 16 weeks
Time Frame
Sixteen weeks
Title
Change from Baseline in family APGAR at 8 weeks
Time Frame
Eight weeks
Title
Change from Baseline in family APGAR at 16 weeks
Time Frame
sixteen weeks
Title
Change from Baseline in Duke-UNC-11 questionnaire of functional social support at 8 weeks
Time Frame
Eight weeks
Title
Change from Baseline in Duke-UNC-11 questionnaire of functional social support at 16 weeks
Time Frame
Sixteen weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Having an habitual role of carer (informal or formal). Being caring a mild-moderate poststroke patient with upper limb apraxia. Subjective manifestations of overload in the role as carer. More than two month as carer. Exclusion Criteria: Uncooperativeness Being formed in the care of that kind of patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mª Encarnacion ME Aguilar, PhD
Organizational Affiliation
Department of Physiotherapy. Faculty of Sciences of Health. University of Granada (Granada). Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Granada
City
Granada
State/Province
Andalucía
ZIP/Postal Code
18071
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Intervention on Caregivers Caring for Patients Poststroke With Upper Limb Apraxia

We'll reach out to this number within 24 hrs