NCT00646217

Brief Summary

Most stroke survivors return home, where their care is supported by family and friends. Although family caring at home is usually rewarding, it is often challenging, too. The demands and responsibilities of caring for a loved one at home can be stressful. The actual activities of caregiving vary according to the needs of the stroke survivor, but can include helping with bathing, dressing, eating, and many other activities. Caregivers must learn care techniques and how to manage changes in roles and lifestyle. While adjusting to these changes, caregivers may be advised to 'take care' of themselves, but may not receive guidance or support for doing this. In this study, we are testing a self-care intervention for older, spouse caregivers of persons with stroke to see how helpful the intervention is in reducing distress and in helping caregivers adopt and maintain healthy lifestyle behaviors. We have developed an intervention for caregivers that is called Self-Care TALK. The intervention includes creating a health-promoting, self-care education and support partnership between caregivers and nurses through the use of weekly telephone conversations. Each conversation focuses on a health-related topic, such as: healthy habits, building self-esteem, focusing on the positive, avoiding role overload, communicating, and building meaning. The conversations follow a basic format, but also are unique to each person. Participants complete questionnaires before and after the intervention, so that we can test the effect of participation in Self-Care TALK on caregiver health. We know that education and support about self-care can be achieved through partnerships between family caregivers and health care professionals. Our goal is to build on this knowledge in testing whether participation in the Self-Care TALK intervention will result in less distress and better health and well-being for spouse caregivers, compared to caregivers who receive no additional care beyond usual education and support. In working toward this goal, we are using a partnership approach, in which nurses and caregivers discuss several health-related topics and mutually identify creative solutions for caregivers to incorporate self-care and health-promotion strategies into their daily routines. Promoting healthy outcomes for caregivers is essential to supporting their personal well-being, and to fostering their ability to continue home care for their loved one.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

2.7 years

First QC Date

March 25, 2008

Last Update Submit

November 23, 2016

Conditions

Keywords

SELF Care TalkstrokecaregiversCaregiving as experienced by older adults caring for a spouse/partner with a first-ever stroke

Outcome Measures

Primary Outcomes (1)

  • SF-36v2, PCS (perceived physical health) SF-36v2, MCS (perceived mental health)

    2 months and 6 months post enrollment

Secondary Outcomes (1)

  • M-CSI: modified (caregiver strain),SRAHP (self efficacy for health), CED-D (depression)

    2 and 6 months post enrollment

Study Arms (2)

1

EXPERIMENTAL

SELF CARE Talk

Behavioral: Self Care Talk

2

NO INTERVENTION

Comparison Group

Interventions

Self Care TalkBEHAVIORAL

6 weekly telephone sessions

1

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 55 years or older
  • Married or married equivalent
  • Living with and caring for a spouse/partner surviving a first-ever stroke occurring 6 - 36 months before enrollment
  • Can participate by telephone
  • Speaks English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Cynthia Teel, PhD, RN

    University of Kansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2008

First Posted

March 28, 2008

Study Start

July 1, 2005

Primary Completion

March 1, 2008

Study Completion

February 1, 2010

Last Updated

November 28, 2016

Record last verified: 2016-11

Locations