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Completed

NCT Number: NCT03712410

A Problem Solving Intervention for Hospice Caregivers

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.

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Key information

Conditions

Anxiety Generalized Anxiety Disorders Behavior Behavioral Symptoms Depression Generalized Anxiety Disorder Mental Disorders Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PISCES

Behavioral

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

Primary outcomes

  1. Table 2. Comparison of 4 Groups

    Time frame: from baseline to follow-up (prior to intervention-day 1 to post intervention-approx. day 30)

    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)

  2. Table 3. Comparison of Traditional PISCES vs. Online PISCES

    Time frame: 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)

    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

  3. Table 4. Within-Group Comparison Baseline vs. Follow-up

    Time frame: from baseline to follow-up (time point 1 is pre-intervention-day 0 and time point 2 is post-intervention-approx. day 30)

    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

Sponsors and collaborators

Lead sponsor

George Demiris, PhD

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 19, 2018
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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