Performance AnxietyCPANCT02307019
Intervention on Caregivers Caring for Patients Poststroke With Upper Limb Apraxia
A study testing Program on specific prevention of health and Program on general prevention of health in people with Performance Anxiety and Emotional Stress, run by Universidad de Granada at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Performance Anxiety, Emotional Stress
- What is being tested?
- Program on specific prevention of health and Program on general prevention of health
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2014to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Uncooperativeness
- Being formed in the care of that kind of patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Performance Anxiety, Emotional Stress
- Being tested
- Program on specific prevention of health, Program on general prevention of health
- Keywords
- Caregivers, Apraxias, Stroke, Cerebral Stroke, Rehabilitation, Pragmatic Clinical Trials as Topic
- Medical subject headings
- Stress, Psychological, Apraxias, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program on specific prevention of healthOther
Also called Program of specific intervention for caregivers
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 healthOther
Also called Program on traditional intervention for caregivers
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Program on general prevention of health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Stroke Impact Scale (SIS-16) at 8 weeks
Measured: Eight weeks
Change from Baseline in Stroke Impact Scale (SIS-16) at 16 weeks
Measured: Sixteen weeks
Secondary outcomes (12)
Change from Baseline in Barthel index at 8 weeks
Measured: Eight weeks
Change from Baseline in Barthel index at 16 weeks
Measured: Sixteen weeks
Change from Baseline in Disabilities of the Arm, Shoulder and Hand (Quick-DASH) at 8 weeks
Measured: Eight weeks
Change from Baseline in Disabilities of the Arm, Shoulder and Hand (Quick-DASH) at 16 weeks
Measured: Sixteen weeks
Change from Baseline in General health questionnaire (GHQ-28) at 8 weeks
Measured: Eight weeks
Change from Baseline in General health questionnaire (GHQ-28) at 16 weeks
Measured: Sixteen weeks
Change from Baseline in Zarit questionnaire at 8 weeks
Measured: Eight weeks
Change from Baseline in Zarit questionnaire at 16 weeks
Measured: Sixteen weeks
Change from Baseline in family APGAR at 8 weeks
Measured: Eight weeks
Change from Baseline in family APGAR at 16 weeks
Measured: sixteen weeks
Change from Baseline in Duke-UNC-11 questionnaire of functional social support at 8 weeks
Measured: Eight weeks
Change from Baseline in Duke-UNC-11 questionnaire of functional social support at 16 weeks
Measured: Sixteen weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Performance AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Encarnación Aguilar Ferrandiz, Universidad de Granada
- Investigators
- Mª Encarnacion ME Aguilar, PhD, Principal investigator, Department of Physiotherapy. Faculty of Sciences of Health. University of Granada (Granada). Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307019
- Sponsor's protocol ID
- Caregiver patients apraxia
- Acronym
- CPA
- Status last verified
- Oct 2018
- First submitted
- 1 Dec 2014
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention on Caregivers Caring for Patients Poststroke With Upper Limb Apraxia: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02307019
- Acronym / sponsor ID
- CPA / Caregiver patients apraxia
- Conditions
- Performance Anxiety, Emotional Stress
- Keywords
- Caregivers, Apraxias, Stroke, Cerebral Stroke, Rehabilitation, Pragmatic Clinical Trials as Topic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 3 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Program on specific prevention of health | Experimental | Other: Program on specific prevention of healthThe 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. |
| Program on general prevention of health | Active comparator | Other: Program on general prevention of healthControl 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Uncooperativeness
- Being formed in the care of that kind of patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Program on specific prevention of healthAlso: Program of specific intervention for caregiversThe 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 | Program on specific prevention of health |
| Program on general prevention of healthAlso: Program on traditional intervention for caregiversThe 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 | Program on general prevention of health |
Primary outcome
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
12 secondary outcomes
Change from Baseline in Barthel index at 8 weeks
Time frame: Eight weeks
Change from Baseline in Barthel index at 16 weeks
Time frame: Sixteen weeks
Change from Baseline in Disabilities of the Arm, Shoulder and Hand (Quick-DASH) at 8 weeks
Time frame: Eight weeks
Change from Baseline in Disabilities of the Arm, Shoulder and Hand (Quick-DASH) at 16 weeks
Time frame: Sixteen weeks
Change from Baseline in General health questionnaire (GHQ-28) at 8 weeks
Time frame: Eight weeks
Change from Baseline in General health questionnaire (GHQ-28) at 16 weeks
Time frame: Sixteen weeks
Change from Baseline in Zarit questionnaire at 8 weeks
Time frame: Eight weeks
Change from Baseline in Zarit questionnaire at 16 weeks
Time frame: Sixteen weeks
Change from Baseline in family APGAR at 8 weeks
Time frame: Eight weeks
Change from Baseline in family APGAR at 16 weeks
Time frame: sixteen weeks
Change from Baseline in Duke-UNC-11 questionnaire of functional social support at 8 weeks
Time frame: Eight weeks
Change from Baseline in Duke-UNC-11 questionnaire of functional social support at 16 weeks
Time frame: Sixteen weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mª Encarnacion ME Aguilar, PhD principal investigator
Department of Physiotherapy. Faculty of Sciences of Health. University of Granada (Granada). Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Program on specific prevention of health and Program on general prevention of health in people with Performance Anxiety and Emotional Stress, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Stroke Impact Scale (SIS-16) at 8 weeks (time frame: Eight weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2018.