Hospice Problem Solving Intervention

Not Applicable

Completed

• Conditions: Hospice Informal Caregivers
• Interventions: Behavioral: Problem Solving Therapy

• Registration Number: NCT01444027
• Lead Sponsor: University of Washington

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-28
• Study First Submitted QC: 2011-09-29
• Study First Posted: 2011-09-30
• Study Start: 2011-10
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2017-10-19
• Results First Submitted QC: 2017-10-19
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-17
• Results First Posted: 2017-11-20
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 514

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

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Exclusion Criteria

• lack of phone or Internet access

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group 1 (Face to Face)	Problem Solving Therapy	This group receives Problem Solving Therapy in face to face visits.
Intervention Group 2 (Video)	Problem Solving Therapy	This group receives Problem Solving Therapy via video.

Primary Outcome Measures

Name	Time	Method
Caregiver Anxiety: Change From Baseline to Post-Intervention Exit	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 - Financial: Change From Baseline to Post-Intervention Exit	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.
Caregiver Quality of Life - Emotional: Change From Baseline to Post-Intervention Exit	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 - Physical: Change From Baseline to Post-Intervention Exit	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	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.

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States