Hospice Problem Solving Intervention

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
George Demiris, University of Washington
ClinicalTrials.gov Identifier:
NCT01444027
First received: September 28, 2011
Last updated: September 27, 2014
Last verified: September 2014
  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 Phase
Hospice Informal Caregivers
Behavioral: Problem Solving Therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 University of Washington:

Primary Outcome Measures:
  • Caregiver Anxiety [ Time Frame: at baseline and exit (approximately 4 weeks after recruitment) and post intervention (approx. 40 days after exit) ] [ Designated as safety issue: No ]
  • Caregiver Quality of Life [ Time Frame: at baseline and exit (approximately 4 weeks after recruitment) and post intervention (approx. 40 days after exit) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Problem Solving Inventory [ Time Frame: at baseline and exit (approximately 4 weeks after recruitment) and post intervention (approx. 40 days after exit) ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: January 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01444027

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
  More Information

No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: George Demiris, Principal Investigator, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01444027     History of Changes
Other Study ID Numbers: RNR012213A
Study First Received: September 28, 2011
Last Updated: September 27, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 29, 2014