- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02074501
Intervention in Informal Caregivers Who Care Older People After a Stroke: a Pilot Study in Northern Portugal (InCARE)
Supporting Older People's Informal CAREgivers at Home Through InCARE Programme
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Norte
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Braga, Norte, Portugal, 4755-577
- Odete Araújo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
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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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: training 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; (iii) using telephone support, counselling caregivers on 3rd, 6th, 8th and 10th weeks post discharge.
It aims at facilitating the caregivers 'adjustment to stroke demands, increasing knowledge and practical skills to support their decision-making.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Empowerment to self-care in informal caregivers
Time Frame: 65 years
|
The 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. |
65 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Burden
Time Frame: 65
|
Secondary 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. |
65
|
Health quality of life
Time Frame: 65
|
Secondary 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. |
65
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Odete Araújo, PhDs;MSc;RN, University of Minho
Publications and helpful links
General Publications
- Truelsen T, Piechowski-Jozwiak B, Bonita R, Mathers C, Bogousslavsky J, Boysen G. Stroke incidence and prevalence in Europe: a review of available data. Eur J Neurol. 2006 Jun;13(6):581-98. doi: 10.1111/j.1468-1331.2006.01138.x.
- Grant JS, Elliott TR, Weaver M, Bartolucci AA, Giger JN. Telephone intervention with family caregivers of stroke survivors after rehabilitation. Stroke. 2002 Aug;33(8):2060-5. doi: 10.1161/01.str.0000020711.38824.e3.
- Kalra L, Evans A, Perez I, Melbourn A, Patel A, Knapp M, Donaldson N. Training carers of stroke patients: randomised controlled trial. BMJ. 2004 May 8;328(7448):1099. doi: 10.1136/bmj.328.7448.1099.
- Larson J, Franzen-Dahlin A, Billing E, Arbin M, Murray V, Wredling R. The impact of a nurse-led support and education programme for spouses of stroke patients: a randomized controlled trial. J Clin Nurs. 2005 Sep;14(8):995-1003. doi: 10.1111/j.1365-2702.2005.01206.x.
- Marsden D, Quinn R, Pond N, Golledge R, Neilson C, White J, McElduff P, Pollack M. A multidisciplinary group programme in rural settings for community-dwelling chronic stroke survivors and their carers: a pilot randomized controlled trial. Clin Rehabil. 2010 Apr;24(4):328-41. doi: 10.1177/0269215509344268. Epub 2010 Feb 22.
- McBride KL, White CL, Sourial R, Mayo N. Postdischarge nursing interventions for stroke survivors and their families. J Adv Nurs. 2004 Jul;47(2):192-200. doi: 10.1111/j.1365-2648.2004.03078.x.
- Correia M, Silva MR, Matos I, Magalhaes R, Lopes JC, Ferro JM, Silva MC. Prospective community-based study of stroke in Northern Portugal: incidence and case fatality in rural and urban populations. Stroke. 2004 Sep;35(9):2048-53. doi: 10.1161/01.STR.0000137606.34301.13. Epub 2004 Jul 15.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 44/2013
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