This trial is active, not recruiting.

Condition psychological adaptation
Treatments caregiver problem-solving intervention, wait list control
Sponsor Northwestern University
Collaborator Rehabilitation Institute of Chicago
Start date April 2005
End date December 2009
Trial size 362 participants
Trial identifier NCT01141738, R01-NR09077-01


Intervention studies for stroke caregivers (CG's) during early caregiving are few and have met with limited success. The Post-Stroke Rehabilitation Clinical Practice Guidelines (1995) recommend sensitivity to the adverse effects of caregiving on family functioning and CG health. Breakdown of the informal care system can lead to premature introduction of formal services, excess disability, and decline in well-being for stroke survivor and CG alike. Thus, it is important to attempt to prevent the chronic distress of stroke CGs through an early intervention that prevents and remediates distress, coaches problem-solving and other coping skills, can affect multiple outcomes, has durable effects, and is non-threatening and accessible. The proposed intervention will incorporate these features and will be low cost and feasible for use in clinical practice; it will target outcomes important to stroke CGs, depression, anxiety, caregiver preparedness, perceptions of life changes, family functioning, and survivor functioning. The individual format will make it possible to address life stage needs and cultural issues. Given the prevalence of distress in chronic stroke CGs, early intervention to prevent and mediate negative outcomes is essential.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (subject)
Primary purpose supportive care
The experimental treatment will provide structured information, guided problem-solving, and training in skills for coping with stress and emotional responses (e.g., relaxation, cognitive reframing, changing negative problem orientation, PS skills).
caregiver problem-solving intervention
Subjects will meet for two counseling sessions while their family member is hospitalized and will receive the treatment manual, which contains the content for the 10 sessions, work sheets, and handouts. The standardized content will be complemented by tailoring to the specific concerns and problems of CGs which are influenced by culture and developmental life stage as well as the stroke and other environmental and personal factors. Problems specific to stroke caregiving are emphasized. After the stroke survivor has been discharged, the counselor will contact the CG weekly by phone for 5 weeks and then bi-weekly for the next three sessions (a total of 10 sessions) at times convenient for the CG.
WLC subjects will be offered an intervention after the 6 month assessment. Both groups will receive standard services provided by the rehabilitation team to CGs of stroke survivors.
wait list control
Subjects in the WLC condition will receive usual patient and family education. If these subjects are noted to be distressed when assessment measures are administered or during conversation, the research assistant (RA) will inform the PI or Co-PI, who will follow-up. To aid retention, a counselor who is naïve to the CPSI will call the WLC subjects in the second and fifth months post-discharge to check contact information and ask how they are doing. Access to individual or group therapy through community resources during this study will be monitored during routine data collection. Following the T3 assessment, the WLC subjects will be offered a minimal intervention (receipt of the Adapting to Stress booklet 100 and five 30 minute telephone sessions).

Primary Outcomes

The Center for Epidemiologic Studies Depression scale (CES D)
time frame: 12 months post discharge
Profile of Moods Scale short form (POMS)
time frame: 12 months post discharge
The Preparedness for Caregiving Scale
time frame: 12 months post discharge
The Bakas Caregiving Outcomes scale (BCOS)
time frame: 12 months post discharge
The General Functioning Scale of the McMaster Family Assessment Device (FAD)
time frame: 12 months post discharge
The Functional Independence Measure (FIM)
time frame: 12 months post discharge
Social Problem Solving (SPSI-R)
time frame: 12 months post discharge

Secondary Outcomes

Unmet Resource Needs (URN)
time frame: Pre-discharge; 3, 6 and 12 months post discharge
The Appraisal of Caregiving Scale Revised (ACS-R)
time frame: Pre-discharge; 3, 6 and 12 months post discharge
The Center for Epidemiologic Studies Depression scale (CES D) - Patient
time frame: Pre-discharge; 3, 6 and 12 months post discharge

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - Caregiver aged 21 or older, - Primary caregiver for and living with a recent adult stroke survivor who is planning to return home from acute rehabilitation. Exclusion Criteria: - Subjects who are diagnosed with a major psychiatric disorder and/or in individual, group or supportive therapies will be excluded from the study; however, only caregivers who obtain a score of 10 or greater on the study depression measure (CES-D) will be included. - Subjects also will require sufficient hearing and telephone access to be available for the phone segment of the intervention and assessment.

Additional Information

Official title National Institute of Nursing Research #R01 NR09077-01: Problem-solving: A Stroke Caregiver Early Intervention
Principal investigator Rosemarie B King, R.N., Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Northwestern University.