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

Intervention on Caregivers Caring for Patients Poststroke With Upper Limb Apraxia: Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Emotional Stress; Performance Anxiety
• Intervention / Treatment: Other: Program on specific prevention of health; Other: Program on general prevention of health

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Andalucía
    • Granada, Andalucía, Spain, 18071
      • University of Granada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Stroke Impact Scale (SIS-16) at 8 weeks	Eight weeks
Change from Baseline in Stroke Impact Scale (SIS-16) at 16 weeks	Sixteen weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: December 1, 2014
• First Submitted That Met QC Criteria: December 1, 2014
• First Posted (Estimate): December 3, 2014

Study Record Updates

• Last Update Posted (Actual): October 5, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; Caregivers; Cerebral Stroke; Apraxias; Pragmatic Clinical Trials as Topic
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Psychomotor Disorders; Apraxias
• Other Study ID Numbers: Caregiver patients apraxia