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Completed

NCT Number: NCT02307019

Intervention on Caregivers Caring for Patients Poststroke With Upper Limb Apraxia

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.

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Key information

Conditions

Performance Anxiety Apraxias Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Emotional Stress Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Disorders Signs and Symptoms Stress, Psychological Stroke Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Granada

Granada, Andalusia, 18071, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Program of specific intervention for caregivers

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.

Other names: Program on traditional intervention for caregivers

Primary outcomes

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

    Time frame: Eight weeks

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

    Time frame: Sixteen weeks

Secondary outcomes

  1. Change from Baseline in Barthel index at 8 weeks

    Time frame: Eight weeks

  2. Change from Baseline in Barthel index at 16 weeks

    Time frame: Sixteen weeks

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

    Time frame: Eight weeks

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

    Time frame: Sixteen weeks

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

    Time frame: Eight weeks

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

    Time frame: Sixteen weeks

  7. Change from Baseline in Zarit questionnaire at 8 weeks

    Time frame: Eight weeks

  8. Change from Baseline in Zarit questionnaire at 16 weeks

    Time frame: Sixteen weeks

  9. Change from Baseline in family APGAR at 8 weeks

    Time frame: Eight weeks

  10. Change from Baseline in family APGAR at 16 weeks

    Time frame: sixteen weeks

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

    Time frame: Eight weeks

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

    Time frame: Sixteen weeks

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

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

Acronym: CPA

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 3, 2014
Registry last updated
Oct 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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