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Intervention in Informal Caregivers Who Care Older People After a Stroke: a Pilot Study in Northern Portugal

Supporting Older People's Informal CAREgivers at Home Through InCARE Programme

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02074501
Acronym
InCARE
Enrollment
158
Registered
2014-02-28
Start date
2014-01-31
Completion date
2014-10-31
Last updated
2014-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular Disorder

Keywords

stroke, elderly, caregivers, empowerment, self-care, pilot study

Brief summary

Background: More than 42% of older people (aged +65) have a stroke and most of them require some type of help to self-care at home. Informal caregivers have reported different types of need and have shown dissatisfaction with technical and emotional support delivered by community health teams. Furthermore, empowering informal caregivers who care after older stroke survivors is an important challenge, preventing them from negative outcomes such as burden, anxiety and depression or loss of physical function or hospitalization in older people. Objectives: This pilot study aims to implement and evaluate the impact of an intervention based on training and telephone support delivered to informal caregivers who care after older people post-stroke. Setting: Community health units in Northern Portugal region. Design/Methods: This single blinded randomized trial will be delivered by a community nursing team to informal caregivers 1 week, 1 and 3 months after a hospital discharge. Study outcome(s): The primary outcomes will be informal caregivers´ empowerment. Secondary outcomes will include burden and health quality of life in caregivers; functionality, hospital readmission and institutionalization of older people stroke survivors, measured 1 and 3 months after intervention. Results/Conclusion: Data collection started in February and will be concluded in August 2014. First results will be published at the beginning of 2015. The InCARE programme will be the first pilot in informal caregivers study ever conducted in Portugal. It will highlight new ways to support caregivers who take care of older people after a stroke. If successful, this study will be translational and it will also allow to disseminate the results in Portugal and abroad and implement it as best practice.

Detailed description

InCare study has a purpose to implement and evaluate an intervention delivered to informal caregivers who care for older people after a stroke.

Interventions

OTHERtraining capacity in caregivers

The participants of the InCARE programme (intervention group) will receive, additionally, intervention based on: (i) empowering caregivers to put hands on caring, which will be the key-point of the pilot programme; (ii) training handling techniques: mobility, bathing, (un)dressing, transferring, positioning, eating and drinking using technical aids, after 1 week, 1 month and 3 months, post hospital discharge.

Sponsors

University of Minho
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Informal caregivers are eligible to participate in the InCARE programme if they meet the following inclusion criteria: (i) to be able to communicate and learn (2) not to have a cognitive disease; (3) to live in the Cávado Region covered by ACES I, II and III; (4) to return the informed consent. In addition, older stroke survivors will enter in this study if they had a stroke for the 1st time and which have become dependent for activities of daily living. \-

Exclusion criteria

Involvement in the InCARE programme requires to communicate frequently, face to face or on the phone, with the nursing staff. Informal caregivers will also be excluded in all the situations in which the provision of older people care is taken by formal support.

Design outcomes

Primary

MeasureTime frameDescription
Empowerment to self-care in informal caregivers65 yearsThe primary outcomes will be informal caregivers´ empowerment to self-care. measured by ECPICID-AVC tool. This outcome will be measure 1 week and 1 month post discharge at home. The primary analysis will be performed according to the intention-to-treat principle.

Secondary

MeasureTime frameDescription
Burden65Secondary outcomes will include Burden measure by QUASCI tool in informal caregivers. This outcome will be measured 1 and 3 months after InCARE programme. All participants will be recruited through the community staff. This study will include a sample size of 79 informal caregivers and stroke survivors for each group. The descriptive statistics will describe the participants' characteristics through SPSS software.
Health quality of life65Secondary outcomes will include Health quality of life measure by SF-36 tool in informal caregivers. This outcome will be measured 1 and 3 months after InCARE programme. All participants will be recruited through the community staff. This study will include a sample size of 79 informal caregivers and stroke survivors for each group. The descriptive statistics will describe the participants' characteristics through SPSS software.

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026