A Problem Solving Intervention for Hospice Caregivers

Depression Clinical Trial

Official title:

A Problem Solving Intervention for Hospice Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03712410
• Other study ID #: 828990
• Secondary ID: R01NR012213
• Status: Completed
• Phase: N/A
• Start date: October 23, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hospice care is conceptualized as quality compassionate care for people facing a life-limiting illness, with services that cover clinical care, pain management, and emotional and spiritual support tailored to patients' and families' needs and preferences. Family members, spouses, friends or others who assume the unpaid or informal caregiving role are essential to the delivery of hospice services; however, stress and caregiver burden can negatively affect caregivers' morbidity and mortality. The emotional needs of individuals caring for dying persons at home are not well attended, and interventions aiming to provide support to hospice caregivers are notably lacking. The investigator team recently completed a study with 514 hospice caregivers to test a problem-solving therapy (PST) intervention tailored specifically for the hospice setting, entitled PISCES (Problem-solving Intervention to Support Caregivers in End of Life care Settings). The findings demonstrate that the PISCES intervention when delivered face to face was effective leading to statistically significant decrease in anxiety and increase in quality of life when compared to the other groups (video group and attention control). An additional lesson learned from that RCT study was that caregivers wanted to focus not only on specific problems or challenges, but also on recognizing the positive aspects of caregiving. This approach of positive reappraisal has been found to enhance problem solving interventions in other settings. The specific aims of this new study are: 1) to compare the effectiveness of the PISCES intervention when delivered face to face and when delivered in a hybrid platform (with the first session in person and remaining sessions via video) to hospice caregivers; 2) to compare the effectiveness of the PISCES intervention to the refined PISCES intervention (PISCESplus) that integrates positive reappraisal elements; 3) to assess caregivers' perceptions of and satisfaction with the PISCESplus intervention; and 4) to conduct a cost analysis of the three intervention groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 523
• Est. completion date: December 30, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)
• speak and read English, with at least a 6th-grade education

Exclusion Criteria:

• hearing or visual impairment that prohibits from conducting phone conversations or video conference sessions

Related Conditions & MeSH terms

• Anxiety Generalized
• Depression
• Quality of Life

Intervention

Behavioral:
• PISCES
The intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
George Demiris, PhD	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Table 2. Comparison of 4 Groups	Comparison of 4 groups; Generalised Anxiety Disorder Assessment (GAD-7) minimum 0 maximum 21 higher scores mean a worse outcome (more anxiety); Patient Health Questionnaire 9 (PHQ9) minimum 0 maximum 37 higher scores mean a worse outcome (more distress); Caregiver Quality of Life Index (CQLI-R) minimum 0 maximum 40 higher scores mean a better outcome (better quality of life)	from baseline to follow-up (prior to intervention-day 1 to post intervention-approx. day 30)
Primary	Table 3. Comparison of Traditional PISCES vs. Online PISCES	Comparison of Traditional PISCES vs. Online PISCES; Generalised Anxiety Disorder Assessment (GAD-7) minimum 0 maximum 21 higher scores mean a worse outcome (more problems); Patient Health Questionnaire 9 (PHQ9) minimum 0 maximum 37 higher scores mean a worse outcome; Caregiver Quality of Life Index (CQLI-R) minimum 0 maximum 40 higher scores mean a better outcome	from baseline to follow-up (time point 1 is pre-intervention, i.e., day 0 and time point 2 is post-intervention, approx. day 30)
Primary	Table 4. Within-Group Comparison Baseline vs. Follow-up	Within-Group Comparison Baseline vs. Follow-up; Generalised Anxiety Disorder Assessment (GAD-7) minimum 0 maximum 21 higher scores mean a worse outcome (more problems); Patient Health Questionnaire 9 (PHQ9) minimum 0 maximum 37 higher scores mean a worse outcome; Caregiver Quality of Life Index (CQLI-R) minimum 0 maximum 40 higher scores mean a better outcome	from baseline to follow-up (time point 1 is pre-intervention-day 0 and time point 2 is post-intervention-approx. day 30)