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Nursing Home Care Intervention Post Stroke (SHARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02807012
Recruitment Status : Active, not recruiting
First Posted : June 21, 2016
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:

Associated with the worsening of functional capacity of older adult and the lack of guidance on how to care of them after stroke, the family caregiver starts to fell burden related to the care, and the quality of life was affected by that burden. Besides that, the older adult began to use more frequently health services and had more hospitalizations by preventable conditionals with adequate care.

The aim of this study is to evaluate the effectiveness of educational interventions of care at home provide by nurses to family caregivers of older adult with stroke after hospital discharge, compared with usual care guidelines or no guidance, in one month follow up. The family caregivers of older adults post stroke with the first functional sequel from the Clinical Hospital of Porto Alegre (HCPA) will participate in the study.

The intervention will involve the systematic monitoring of nurses through home visits (HVs) during one month. Thus, will instrumentalize the family caregiver to care of older adult with stoke according the protocol developed in a research group and the needs of care of them. The control group won't receive the home visits and could have or not the usual care guidelines provide by health services that have access.


Condition or disease Intervention/treatment Phase
Stroke Other: Nursing educational intervention Not Applicable

Detailed Description:

Associated with the worsening of functional capacity of older adult and the lack of guidance on how to care of them after stroke, the family caregiver starts to fell burden related to the care and the quality of life was affected by that burden. Besides that, the older adult began to use more frequently health services and had more hospitalizations by preventable conditionals with adequate care.

The aim of this study is to evaluate the effectiveness of educational interventions of care at home provide by nurses to family caregivers of older adult with stroke after hospital discharge, compared with usual care guidelines or no guidance, in one month follow up. The family caregivers of older adults post stroke with the first functional sequel from the Clinical Hospital of Porto Alegre (HCPA) will participate in the study. The randomization will be through the randomization list created by web page randomization.com.

The intervention will involve systematic monitoring of nurses through home visits (HVs) during one month. Thus, will instrumentalize the family caregiver to care of older adult with stoke according the protocol developed in a research group and the needs of care of them. The control group won't receive the HVs and could have or not the usual care guidelines provide by health services that have access.

Will be collect the identification, social and demographics data of the older adults and the caregivers at the moment of hospital discharge. Therefore, will be collect the clinical data of the older adults. After discharge and at the older adult's home, will be realized the first home visit (1ª HV) to all older adults and caregivers included in the study and will be applied to the family caregiver the Caregiver Burden Scale and the instrument WHOQOL-BREF that analyse the quality of life. Also, will be applied the Measure of Functional Independence (MIF) to identify the independence level of the older adults and the needs of care. In this moment, will be randomized by an extern member of research group through telephone contact. After this first HV, the older adults and caregivers included in the intervention group will received more three HVs, until 14, 21 and 30 days after discharge, respectively, by a pair of interventional nurses.

The control group won't receive the home visits by nurses, but could have or not the usual care guidelines provide by health services that have access.

All older adults and caregivers included in the study will received a fifth HV until 60 days after discharge. In this last HV will be applied to family caregiver the Caregiver Burden Scale and the instrument WHOQOL-BREF. In addition, will be applied a questionnaire related older adult's utilization of health services and rehospitalizations during this time and the MIF.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Nursing Home Care Educational Intervention for Family Caregivers of Older Adults Post Stroke
Actual Study Start Date : May 2016
Actual Primary Completion Date : July 2018
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nursing educational intervention
The intervention will consist in three home visits (14, 21, 30 days after discharge) by nurses to family caregivers. The nurses will give verbal information and printed materials related to the care of older adults por stroke.
Other: Nursing educational intervention

The nursing educational intervention by home visits will consist in three home visits by nurses until 14, 21 and 30 days after discharge to the intervention group. The nurses will give verbal information to family caregiver related to the care of elderly with stroke based on protocol with orientation related: information about stroke; emotional support; how to access health services; nutrition; airway; hygiene; positioning and transferring; prevent falls; dress/undress; medications; physiological eliminations; skin care. Furthermore, nurses will give some printed materials that contain orientations related to the care.

The control group could have ou not the usual care guidelines provide by health services that have access.


No Intervention: Usual care
The family caregivers won't receive the home visits and could have or not the usual care guidelines provide by health services that have access.



Primary Outcome Measures :
  1. The family caregiver's burden of care analyzed by Caregiver Burden Scale [ Time Frame: 2 months ]
    The family caregiver burden of care will be analyzed by Caregiver Burden Scale.


Secondary Outcome Measures :
  1. The family caregiver's quality of life analyzed by instrument WHOQOL-BREF [ Time Frame: 2 months ]
    The family caregiver quality of life will be analyzed by instrument WHOQOL-BREF.

  2. The elderly's functional capacity [ Time Frame: 2 months ]
    The elderly functional capacity will be analyzed by the instrument Measure of Functional Independence

  3. The elderly's health service utilization [ Time Frame: 2 months ]
    The elderly health service utilization will be assessed by an questionnaire developed for this study. The answers will be yes or not and analyzed quantitatively.

  4. The elderly's rehospitalization [ Time Frame: 2 months ]
    The elderly rehospitalization will be assessed by an questionnaire developed for this study. The answers will be yes or not and analyzed quantitatively.

  5. The quality of life of family caregiver with 60 years old or older analyzed by instrument WHOQOL-OLD [ Time Frame: 2 months ]
    The family caregiver quality of life will be analyzed by instrument WHOQOL-OLD



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Family caregivers of older adults from the Special Care Unit - stroke (SCU-Stroke) at the moment of discharge;
  • Older adults with diagnosis of stroke with the first sequel identified by minimum score of 2 points from the ranking scale;
  • Older adults who live until 20 kilometers from HCPA;
  • Caregiver will be a family member with consanguineous relationship or not;
  • Caregiver will be responsible for the most part of the older adult's care;
  • Caregiver without payment;
  • Caregiver with 18 year old or more.

Exclusion Criteria:

  • Older adults who live in a Long Term Care Services;
  • Older adults who will be included in a governmental program for Home Care Service;
  • Caregivers who don't accept receive the HV by nurses.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02807012


Locations
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Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Lisiane MG Paskulin, PhD Hospital de Clínicas de Porto Alegre
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02807012    
Other Study ID Numbers: 16-0181
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hospital de Clinicas de Porto Alegre:
Home care services
Nursing
Clinical trial
Geriatric nursing
Family caregiver
Aged
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases