Intervention on Caregivers Caring for Patients Poststroke With Upper Limb Apraxia

NCT02307019 | Completed DMC

• 1 other identifier: Caregiver patients apraxia
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Performance Anxiety; Emotional Stress

Keywords

Caregivers; Apraxias; Stroke; Cerebral Stroke; Rehabilitation; Pragmatic Clinical Trials as Topic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Change from Baseline in Barthel index at 8 weeks

  Eight weeks

• Change from Baseline in Barthel index at 16 weeks

  Sixteen 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

Study Arms (2)

Program on specific prevention of health

EXPERIMENTAL

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

Program on general prevention of health

ACTIVE COMPARATOR

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

Interventions

Program on specific prevention of health OTHER

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.

Also known as: Program of specific intervention for caregivers

Program on specific prevention of health

Program on general prevention of health OTHER

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.

Also known as: Program on traditional intervention for caregivers

Program on general prevention of health

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

University of Granada

Granada, Andalusia, 18071, Spain

Location

MeSH Terms

Conditions

Stress, Psychological; Apraxias; Stroke

Interventions

Caregivers

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Psychomotor Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Mª Encarnacion ME Aguilar, PhD

  Department of Physiotherapy. Faculty of Sciences of Health. University of Granada (Granada). Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Intervention on caregivers caring for patients poststroke with upper limb apraxia: Randomized Clinical Trial

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 3, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: October 5, 2018

Record last verified: 2018-10

Locations

ES (1)