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

NCT02074501 | Unknown DMC

• 1 other identifier: 44/2013
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Empowerment to self-care in informal caregivers

  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 Outcomes (2)

• Burden

  65

• Health quality of life

  65

Study Arms (1)

training capacity in caregivers

OTHER

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.

Other: training capacity in caregivers

Interventions

training capacity in caregivers OTHER

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.

training capacity in caregivers

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minho: lead

Study Sites (1)

Odete Araújo

Braga, Norte, 4755-577, Portugal

Location

Related Publications (7)

• 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.

  PMID: 12154263 BACKGROUND

• 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.

  PMID: 15130977 BACKGROUND

• 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.

  PMID: 16102151 BACKGROUND

• 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.

  PMID: 20176772 BACKGROUND

• 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.

  PMID: 15196193 BACKGROUND

• 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.

  PMID: 16796582 BACKGROUND

• 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.

  PMID: 15256683 BACKGROUND

MeSH Terms

Conditions

Cerebrovascular Disorders; Stroke; Empowerment

Interventions

Caregivers

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Odete Araújo, PhDs;MSc;RN

  University of Minho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: February 28, 2014
• Study Start: January 1, 2014
• Primary Completion: February 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 28, 2014

Record last verified: 2014-02

Locations

PT (1)