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Hospice Problem Solving Intervention

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01444027
First Posted: September 30, 2011
Last Update Posted: December 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
George Demiris, University of Washington
  Purpose
In recent years, the demand for home hospice care has grown rapidly. Family members and friends who act as informal caregivers are essential to the provision of palliative care services; however, this role is not without adverse effects on the caregivers themselves. It is well documented that emotional needs of individuals caring for dying persons in their home are not well attended, and interventions aiming to provide support to informal hospice caregivers are notably lacking. In this context, problem solving therapy (PST) provides an overall coping process that fosters adaptive situational coping and behavioral competence. The investigators are conducting a randomized controlled trial to fully evaluate the PST intervention for informal hospice caregivers. Additionally, the investigators aim to evaluate how the modality of the intervention (face to face vs video) impacts its effectiveness. This investigator team is conducting a 4-year randomized trial study in which hospice caregivers will be randomly assigned to a group receiving standard hospice care with the addition of social support interactions (attention control group) or a group receiving standard hospice care with the addition of the problem solving intervention delivered face to face (intervention group 1) or a group receiving standard hospice care with the addition of the problem solving intervention delivered via video (intervention group 2). The specific aims include an assessment of the impact of PST on caregiver quality of life, problem solving ability, and caregiver anxiety.

Condition Intervention
Hospice Informal Caregivers Behavioral: Problem Solving Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Problem Solving Intervention for Hospice Caregivers

Resource links provided by NLM:


Further study details as provided by George Demiris, University of Washington:

Primary Outcome Measures:
  • Caregiver Anxiety: Change From Baseline to Post-Intervention Exit [ Time Frame: At Baseline and Exit (approximately 4 weeks after recruitment) ]
    Caregiver anxiety was measured with the 7-item Generalized Anxiety Disorder (GAD-7) Scale (Spitzer et al., 2006), which measures the frequency with which respondents experience symptoms of anxiety such as restlessness, difficulty relaxing, and uncontrollable worrying. The GAD-7 total scores range from 0 to 21, with higher scores indicating more anxiety.

  • Caregiver Quality of Life - Physical: Change From Baseline to Post-Intervention Exit [ Time Frame: At Baseline and Exit (approximately 4 weeks after recruitment) ]
    An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better physical quality of life.

  • Caregiver Quality of Life - Social: Change From Baseline to Post-Intervention Exit [ Time Frame: At Baseline and Exit (approximately 4 weeks after recruitment) ]
    An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better social quality of life.

  • Caregiver Quality of Life - Emotional: Change From Baseline to Post-Intervention Exit [ Time Frame: At Baseline and Exit (approximately 4 weeks after recruitment) ]
    An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better emotional quality of life.

  • Caregiver Quality of Life - Financial: Change From Baseline to Post-Intervention Exit [ Time Frame: At Baseline and Exit (approximately 4 weeks after recruitment) ]
    An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better financial quality of life.


Enrollment: 514
Study Start Date: October 2011
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Attention Control
This group receives standard care with the attention of social support/ "friendly interactions" and serves as an attention control group.
Experimental: Intervention Group 1 (Face to Face)
This group receives Problem Solving Therapy in face to face visits.
Behavioral: Problem Solving Therapy
Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist.
Experimental: Intervention Group 2 (Video)
This group receives Problem Solving Therapy via video.
Behavioral: Problem Solving Therapy
Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • enrolled as a family/informal caregiver of a hospice patient
  • 18 years or older
  • with access to a standard phone line or Internet and computer access at home
  • without functional hearing loss or with a hearing aid that allows the participant to conduct telephone conversations as assessed by the research staff (by questioning and observing the caregiver)
  • no or only mild cognitive impairment
  • speak and read English, with at least a 6th-grade education

Exclusion Criteria:

  • lack of phone or Internet access
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01444027


Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: George Demiris, PhD University of Washington
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: George Demiris, Professor, Biobehavioral Nursing and Health Systems, University of Washington
ClinicalTrials.gov Identifier: NCT01444027     History of Changes
Other Study ID Numbers: 36909
1R01NR012213-01A1 ( U.S. NIH Grant/Contract )
First Submitted: September 28, 2011
First Posted: September 30, 2011
Results First Submitted: October 19, 2017
Results First Posted: November 20, 2017
Last Update Posted: December 13, 2017
Last Verified: November 2017