Nursing Home Care Intervention Post Stroke (SHARE)
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Nursing educational intervention
Sponsored by
About this trial
This is an interventional other trial for Stroke focused on measuring Home care services, Nursing, Clinical trial, Geriatric nursing, Family caregiver, Aged
Eligibility 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.
Sites / Locations
- Hospital de Clínicas de Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nursing educational intervention
Usual care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
The family caregiver's burden of care analyzed by Caregiver Burden Scale
The family caregiver burden of care will be analyzed by Caregiver Burden Scale.
Secondary Outcome Measures
The family caregiver's quality of life analyzed by instrument WHOQOL-BREF
The family caregiver quality of life will be analyzed by instrument WHOQOL-BREF.
The elderly's functional capacity
The elderly functional capacity will be analyzed by the instrument Measure of Functional Independence
The elderly's health service utilization
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.
The elderly's rehospitalization
The elderly rehospitalization will be assessed by an questionnaire developed for this study. The answers will be yes or not and analyzed quantitatively.
The quality of life of family caregiver with 60 years old or older analyzed by instrument WHOQOL-OLD
The family caregiver quality of life will be analyzed by instrument WHOQOL-OLD
Full Information
NCT ID
NCT02807012
First Posted
June 3, 2016
Last Updated
August 8, 2019
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT02807012
Brief Title
Nursing Home Care Intervention Post Stroke
Acronym
SHARE
Official Title
Nursing Home Care Educational Intervention for Family Caregivers of Older Adults Post Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Home care services, Nursing, Clinical trial, Geriatric nursing, Family caregiver, Aged
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nursing educational intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Nursing educational intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
The family caregiver's burden of care analyzed by Caregiver Burden Scale
Description
The family caregiver burden of care will be analyzed by Caregiver Burden Scale.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
The family caregiver's quality of life analyzed by instrument WHOQOL-BREF
Description
The family caregiver quality of life will be analyzed by instrument WHOQOL-BREF.
Time Frame
2 months
Title
The elderly's functional capacity
Description
The elderly functional capacity will be analyzed by the instrument Measure of Functional Independence
Time Frame
2 months
Title
The elderly's health service utilization
Description
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.
Time Frame
2 months
Title
The elderly's rehospitalization
Description
The elderly rehospitalization will be assessed by an questionnaire developed for this study. The answers will be yes or not and analyzed quantitatively.
Time Frame
2 months
Title
The quality of life of family caregiver with 60 years old or older analyzed by instrument WHOQOL-OLD
Description
The family caregiver quality of life will be analyzed by instrument WHOQOL-OLD
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisiane MG Paskulin, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34813082
Citation
Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
Results Reference
derived
PubMed Identifier
32602588
Citation
Day CB, Bierhals CCBK, Mocellin D, Predebon ML, Santos NO, Dal Pizzol FLF, Fuhrmann AC, Aires M, Paskulin LMG. Nursing Home Care Intervention Post Stroke (SHARE) 1 year effect on the burden of family caregivers for older adults in Brazil: A randomized controlled trial. Health Soc Care Community. 2021 Jan;29(1):56-65. doi: 10.1111/hsc.13068. Epub 2020 Jun 30.
Results Reference
derived
PubMed Identifier
31800798
Citation
Bierhals CCBK, Day CB, Mocellin D, Santos NOD, Predebon ML, Pizzol FLFD, Fuhrmann AC, Medeiros GG, Aires M, Paskulin LMG. Use of health services by elderly people post-stroke: a randomized controlled trial. Rev Gaucha Enferm. 2019 Dec 2;41(spe):e20190138. doi: 10.1590/1983-1447.2020.20190138. eCollection 2020. English, Portuguese.
Results Reference
derived
PubMed Identifier
29426361
Citation
Day CB, Bierhals CCBK, Santos NOD, Mocellin D, Predebon ML, Dal Pizzol FLF, Paskulin LMG. Nursing home care educational intervention for family caregivers of older adults post stroke (SHARE): study protocol for a randomised trial. Trials. 2018 Feb 9;19(1):96. doi: 10.1186/s13063-018-2454-5.
Results Reference
derived
Learn more about this trial
Nursing Home Care Intervention Post Stroke
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