StrokeSHARENCT02807012
Nursing Home Care Intervention Post Stroke
A study testing Nursing educational intervention in people with Stroke, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Nursing educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteBrazil
- Study dates
- May 2016to Jul 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Nursing Home Care Educational Intervention for Family Caregivers of Older Adults Post Stroke
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Nursing educational intervention
- Keywords
- Home care services, Nursing, Clinical trial, Geriatric nursing, Family caregiver, Aged
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing educational interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Nursing educational intervention | Experimental | 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. Receives: Other: Nursing educational intervention |
| Usual care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (5)
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.
Measured: 2 months
The elderly's functional capacity
The elderly functional capacity will be analyzed by the instrument Measure of Functional Independence
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2018
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisiane MG Paskulin, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807012
- Sponsor's protocol ID
- 16-0181
- Acronym
- SHARE
- Status last verified
- Mar 2019
- First submitted
- 3 Jun 2016
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Bierhals CCBK, Dal Pizzol FLF, Low G, Day CB, Santos NOD, Paskulin LMG. Quality of life in caregivers of aged stroke survivors in southern Brazil: Arandomized clinical trial. Rev Lat Am Enfermagem. 2023 Jan-Dec;31:e3657. doi: 10.1590/1518-8345.5935.3657.
PubMed 36722630Crocker 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.
PubMed 34813082Day 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.
PubMed 32602588Bierhals 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.
PubMed 31800798Day 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.
PubMed 29426361
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Home Care Educational Intervention for Family Caregivers of Older Adults Post Stroke
- ClinicalTrials.gov ID
- NCT02807012
- Acronym / sponsor ID
- SHARE / 16-0181
- Conditions
- Stroke
- Keywords
- Home care services, Nursing, Clinical trial, Geriatric nursing, Family caregiver, Aged
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2020 (estimated)
- First posted
- 21 Jun 2016 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nursing educational intervention | Experimental | Other: Nursing educational interventionThe 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. |
| Usual care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Nursing educational interventionThe 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. | Other | Nursing educational intervention |
Primary outcome
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.
5 secondary outcomes
The family caregiver's quality of life analyzed by instrument WHOQOL-BREF
Time frame: 2 months
The elderly's functional capacity
Time frame: 2 months
The elderly's health service utilization
Time frame: 2 months
The elderly's rehospitalization
Time frame: 2 months
The quality of life of family caregiver with 60 years old or older analyzed by instrument WHOQOL-OLD
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Derived from this study: PubMed 36722630Bierhals CCBK, Dal Pizzol FLF, Low G, Day CB, Santos NOD, Paskulin LMG. Quality of life in caregivers of aged stroke survivors in southern Brazil: Arandomized clinical trial. Rev Lat Am Enfermagem. 2023 Jan-Dec;31:e3657. doi: 10.1590/1518-8345.5935.3657.
- Derived from this study: PubMed 34813082Crocker 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.
- Derived from this study: PubMed 32602588Day 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.
- Derived from this study: PubMed 31800798Bierhals 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.
- Derived from this study: PubMed 29426361Day 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.
- Individual participant dataSharing planned: Undecided
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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.
Lisiane MG Paskulin, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing educational intervention in people with Stroke, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Aug 2019. 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 Brazil. 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?
Results are not available in the source record.
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?
The family caregiver's burden of care analyzed by Caregiver Burden Scale (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02807012, which also lists 5 linked publications.
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 12 Aug 2019.