Hospice Problem Solving Intervention
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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 |
- 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 ]
- 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 |
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| Contact: George Demiris, PhD | 206-221-3866 | gdemiris@uw.edu |
| Contact: Deborah Thomas-Jones, PhD | 206-221-7631 | debitj@uw.edu |
| United States, Washington | |
| University of Washington | Recruiting |
| Seattle, Washington, United States, 98195 | |
| Contact: George Demiris, PhD 206-381-8613 gdemiris@uw.edu | |
More Information
No publications provided
| 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: | January 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on June 18, 2013