Problem-solving: A Stroke Caregiver Early Intervention (CPSI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Northwestern University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Rehabilitation Institute of Chicago
Alexian Brothers Hospital Network
Advocate Health Care
Mount Sinai Hospital, New York
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT01141738
First received: May 10, 2010
Last updated: June 9, 2010
Last verified: June 2010
  Purpose

Intervention studies for stroke caregivers during early caregiving are few and have met with limited success. The Post-Stroke Rehabilitation Clinical Practice Guidelines (1995)77 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.


Condition Intervention
Psychological Adaptation
Behavioral: Caregiver Problem-Solving Intervention
Behavioral: Wait List Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: National Institute of Nursing Research #R01 NR09077-01: Problem-solving: A Stroke Caregiver Early Intervention

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • The Center for Epidemiologic Studies Depression scale (CES D) [ Time Frame: 12 months post discharge ] [ Designated as safety issue: No ]
    The CES D was developed to study depressive symptomatology in community settings. The CES-D measures the frequency and severity of 20 depressive symptoms experienced during the past week.

  • Profile of Moods Scale short form (POMS) [ Time Frame: 12 months post discharge ] [ Designated as safety issue: No ]
    The Profile of Moods Scale short form (POMS) is a 30 item scale that uses a 5 point response set (0 = not at all, 4 = extremely) to assess 6 moods. Predictive, construct, and concurrent validity have been demonstrated. Only the Anxiety sub-scale will be evaluated.

  • The Preparedness for Caregiving Scale [ Time Frame: 12 months post discharge ] [ Designated as safety issue: No ]
    The Preparedness for Caregiving Scale assesses a caregiver's perception of how well prepared they are to manage the tasks and stresses of caregiving. The PCS has been used in studies of CGs of persons with a variety of health needs. It is an 8-item, 5-response option scale (0=not at all prepared to 4=very well prepared).

  • The Bakas Caregiving Outcomes scale (BCOS) [ Time Frame: 12 months post discharge ] [ Designated as safety issue: No ]
    The Bakas Caregiving Outcomes scale (BCOS) measures changes in social functioning, subjective well-being, and somatic health 37. The 16-items with a 7-point response set, 1 ="Changed for the Worst" to 7 ="Changed for the Best" are summed for an overall score that reflect CG life changes. Construct validity was supported by a uni-dimensional factor analysis solution and prediction of the BCOS by stress and coping variables. Criterion validity was supported by significant correlations with a well-being measure.

  • The General Functioning Scale of the McMaster Family Assessment Device (FAD) [ Time Frame: 12 months post discharge ] [ Designated as safety issue: No ]
    This 12 item, 4 point subscale assesses overall health/pathology of the family. The range of scores is 1=healthy to 4=unhealthy. Concurrent validity was supported by predicting 28% of the variance in marital satisfaction. The FAD predicted 17% to 22%, respectively, of the variance in morale scores of husbands and wives. The FAD has been used in stroke studies, was sensitive to change over time and to interventions, and predicted depression.

  • The Functional Independence Measure (FIM) [ Time Frame: 12 months post discharge ] [ Designated as safety issue: No ]
    The FIM measures severity of disability and resultant care burden on six subscales: self care, sphincter control, mobility, locomotion, communication, and social cognition. It uses an 18 item, 7 point scale, 1="maximum dependence" to 7 = "independent function". Two underlying constructs have been identified, a 13-item motor scale and a 5-item cognitive scale (two language and three social cognition items).

  • Social Problem Solving (SPSI-R) [ Time Frame: 12 months post discharge ] [ Designated as safety issue: No ]
    The Social Problem Solving (SPSI-R) short form will be used to assess problem-solving. This 25-item scale contains five subscales that measure two problem-oriented dimensions (positive, negative) and three problem-solving styles (impulsive/careless, avoidance, rational). The responses range from (0= not true to 4= extremely true).


Secondary Outcome Measures:
  • Unmet Resource Needs (URN) [ Time Frame: Pre-discharge; 3, 6 and 12 months post discharge ] [ Designated as safety issue: No ]
    Unmet Resource Needs (URN) will be assessed using a 12-item investigator-generated measure (URN). The items address knowledge and access on resource needs; responses range from 1=strongly disagree to 5=strongly agree.

  • The Appraisal of Caregiving Scale Revised (ACS-R) [ Time Frame: Pre-discharge; 3, 6 and 12 months post discharge ] [ Designated as safety issue: No ]
    ACS-Revised is comprised of three scales (threat, benefit, benign). An adaptation of the original response set will be used. The adapted form was used in two stroke CG samples; alphas ranged from .71(benefit) to .92 (threat)37. Items are rated on a 5-point scale from 1 = "strongly disagree" to 5 = "strongly agree".

  • The Center for Epidemiologic Studies Depression scale (CES D) - Patient [ Time Frame: Pre-discharge; 3, 6 and 12 months post discharge ] [ Designated as safety issue: No ]
    The CES D was developed to study depressive symptomatology in community settings. The CES-D measures the frequency and severity of 20 depressive symptoms experienced during the past week.


Enrollment: 362
Study Start Date: April 2005
Estimated Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Caregiver Problem-Solving Intervention
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).
Behavioral: 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.
Wait List Control
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.
Behavioral: 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).

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141738

Locations
United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
Schwab Rehabilitation Hospital
Chicago, Illinois, United States, 60608
Alexian Brothers Hospital Network
Elk Grove Village, Illinois, United States, 60007
Advocate Health Care
Park Ridge, Illinois, United States, 60068
Sponsors and Collaborators
Northwestern University
Rehabilitation Institute of Chicago
Alexian Brothers Hospital Network
Advocate Health Care
Mount Sinai Hospital, New York
Investigators
Principal Investigator: Rosemarie B King, R.N., Ph.D. Northwestern University
  More Information

No publications provided

Responsible Party: Rosemarie B. King, PhD, R.N., Northwestern University
ClinicalTrials.gov Identifier: NCT01141738     History of Changes
Other Study ID Numbers: R01-NR09077-01
Study First Received: May 10, 2010
Last Updated: June 9, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
stroke
caregiver
depression
mediators
problem-solving

ClinicalTrials.gov processed this record on October 23, 2014