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

Sponsor
Universidad de Granada (Other)
Overall Status
Completed
CT.gov ID
NCT02307019
Collaborator
(none)
50
1
2
50
1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Program on specific prevention of health
  • Other: Program on general prevention of health
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Intervention on Caregivers Caring for Patients Poststroke With Upper Limb Apraxia: Randomized Clinical Trial
Study Start Date :
Jul 1, 2014
Actual Primary Completion Date :
Sep 1, 2018
Actual Study Completion Date :
Sep 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Program on specific prevention of health

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.

Other: Program on specific prevention of health
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.
Other Names:
  • Program of specific intervention for caregivers
  • Active Comparator: Program on general prevention of health

    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.

    Other: Program on general prevention of health
    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.
    Other Names:
  • Program on traditional intervention for caregivers
  • Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in Stroke Impact Scale (SIS-16) at 8 weeks [Eight weeks]

    2. Change from Baseline in Stroke Impact Scale (SIS-16) at 16 weeks [Sixteen weeks]

    Secondary Outcome Measures

    1. Change from Baseline in Barthel index at 8 weeks [Eight weeks]

    2. Change from Baseline in Barthel index at 16 weeks [Sixteen weeks]

    3. Change from Baseline in Disabilities of the Arm, Shoulder and Hand (Quick-DASH) at 8 weeks [Eight weeks]

    4. Change from Baseline in Disabilities of the Arm, Shoulder and Hand (Quick-DASH) at 16 weeks [Sixteen weeks]

    5. Change from Baseline in General health questionnaire (GHQ-28) at 8 weeks [Eight weeks]

    6. Change from Baseline in General health questionnaire (GHQ-28) at 16 weeks [Sixteen weeks]

    7. Change from Baseline in Zarit questionnaire at 8 weeks [Eight weeks]

    8. Change from Baseline in Zarit questionnaire at 16 weeks [Sixteen weeks]

    9. Change from Baseline in family APGAR at 8 weeks [Eight weeks]

    10. Change from Baseline in family APGAR at 16 weeks [sixteen weeks]

    11. Change from Baseline in Duke-UNC-11 questionnaire of functional social support at 8 weeks [Eight weeks]

    12. Change from Baseline in Duke-UNC-11 questionnaire of functional social support at 16 weeks [Sixteen weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Granada Granada Andalucía Spain 18071

    Sponsors and Collaborators

    • Universidad de Granada

    Investigators

    • Principal Investigator: Mª Encarnacion ME Aguilar, PhD, Department of Physiotherapy. Faculty of Sciences of Health. University of Granada (Granada). Spain

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Encarnación Aguilar Ferrandiz, Intervention on caregivers caring for patients poststroke with upper limb apraxia: Randomized Clinical Trial, Universidad de Granada
    ClinicalTrials.gov Identifier:
    NCT02307019
    Other Study ID Numbers:
    • Caregiver patients apraxia
    First Posted:
    Dec 3, 2014
    Last Update Posted:
    Oct 5, 2018
    Last Verified:
    Oct 1, 2018
    Keywords provided by Encarnación Aguilar Ferrandiz, Intervention on caregivers caring for patients poststroke with upper limb apraxia: Randomized Clinical Trial, Universidad de Granada
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 5, 2018