Overview

This trial is active, not recruiting.

Condition hospice informal caregivers
Treatment problem solving therapy
Phase phase 2/phase 3
Sponsor University of Washington
Start date October 2011
End date March 2016
Trial size 300 participants
Trial identifier NCT01444027, RNR012213A

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(No Intervention)
This group receives standard care with the attention of social support/ "friendly interactions" and serves as an attention control group.
(Experimental)
This group receives Problem Solving Therapy in face to face visits.
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)
This group receives Problem Solving Therapy via video.
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.

Primary Outcomes

Measure
Caregiver Anxiety
time frame: at baseline and exit (approximately 4 weeks after recruitment) and post intervention (approx. 40 days after exit)
Caregiver Quality of Life
time frame: at baseline and exit (approximately 4 weeks after recruitment) and post intervention (approx. 40 days after exit)

Secondary Outcomes

Measure
Problem Solving Inventory
time frame: at baseline and exit (approximately 4 weeks after recruitment) and post intervention (approx. 40 days after exit)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Problem Solving Intervention for Hospice Caregivers
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Washington.