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

Sponsor

University of Minho (Other)

Overall Status

Unknown status

CT.gov ID

NCT02074501

Collaborator

(none)

158

Enrollment

Location

Arm

Duration (Months)

17.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Disorder	Other: training capacity in caregivers	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

158 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Feb 1, 2014

Anticipated Study Completion Date :

Oct 1, 2014

Arms and Interventions

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.	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.

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.

Other: training capacity in caregivers

Outcome Measures

Primary Outcome Measures

Empowerment to self-care in informal caregivers [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.

Secondary Outcome Measures

Burden [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.
Health quality of life [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.