Intervention on Caregivers Caring for Patients Poststroke With Upper Limb Apraxia

Emotional Stress Clinical Trial

— CPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02307019
• Other study ID #: Caregiver patients apraxia
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: September 2018

Study information

• Verified date: October 2018
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Apraxias
• Emotional Stress
• Performance Anxiety
• Stress, Psychological

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	University of Granada	Granada	Andalucía

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Stroke Impact Scale (SIS-16) at 8 weeks		Eight weeks
Primary	Change from Baseline in Stroke Impact Scale (SIS-16) at 16 weeks		Sixteen weeks
Secondary	Change from Baseline in Barthel index at 8 weeks		Eight weeks
Secondary	Change from Baseline in Barthel index at 16 weeks		Sixteen weeks
Secondary	Change from Baseline in Disabilities of the Arm, Shoulder and Hand (Quick-DASH) at 8 weeks		Eight weeks
Secondary	Change from Baseline in Disabilities of the Arm, Shoulder and Hand (Quick-DASH) at 16 weeks		Sixteen weeks
Secondary	Change from Baseline in General health questionnaire (GHQ-28) at 8 weeks		Eight weeks
Secondary	Change from Baseline in General health questionnaire (GHQ-28) at 16 weeks		Sixteen weeks
Secondary	Change from Baseline in Zarit questionnaire at 8 weeks		Eight weeks
Secondary	Change from Baseline in Zarit questionnaire at 16 weeks		Sixteen weeks
Secondary	Change from Baseline in family APGAR at 8 weeks		Eight weeks
Secondary	Change from Baseline in family APGAR at 16 weeks		sixteen weeks
Secondary	Change from Baseline in Duke-UNC-11 questionnaire of functional social support at 8 weeks		Eight weeks
Secondary	Change from Baseline in Duke-UNC-11 questionnaire of functional social support at 16 weeks		Sixteen weeks