Intervention on Caregivers Caring for Patients Poststroke With Upper Limb Apraxia: Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad de Granada
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change from Baseline in Stroke Impact Scale (SIS-16) at 8 weeks
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
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.
Intervention: Program on specific prevention of health (Other)
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.
Intervention: Program on general prevention of health (Other)
Outcomes
Primary Outcomes
Change from Baseline in Stroke Impact Scale (SIS-16) at 8 weeks
Time Frame: Eight weeks
Change from Baseline in Stroke Impact Scale (SIS-16) at 16 weeks
Time Frame: Sixteen weeks
Secondary Outcomes
- 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 Barthel index at 16 weeks(Sixteen 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)
- Change from Baseline in General health questionnaire (GHQ-28) at 8 weeks(Eight weeks)
- Change from Baseline in family APGAR at 8 weeks(Eight weeks)
- Change from Baseline in Zarit questionnaire 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 16 weeks(Sixteen weeks)
- Change from Baseline in Zarit questionnaire at 16 weeks(Sixteen weeks)
Investigators
Encarnación Aguilar Ferrandiz
Intervention on caregivers caring for patients poststroke with upper limb apraxia: Randomized Clinical Trial
Universidad de Granada