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Completed

NCT Number: NCT01211340

The ACTIVE Intervention to Improve Hospice Care

The ACTIVE Intervention to Improve Hospice Caregiver Pain Management The major goal of this project is to implement and test this promising intervention in three hospice programs. The mixed methods evaluation of this randomized controlled trial (RCT) will provide evidence-based data for a tested intervention manual that hospice staff members can use to integrate the intervention into their practices.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospice Compassus, Columbia, Missouri, United States

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About this study

The ACTIVE Intervention to Improve Hospice Caregiver Pain Management The major goal of this project is to implement and test this promising intervention in three hospice programs. The mixed methods evaluation of this RCT will provide evidence-based data for a tested intervention manual that hospice staff members can use to integrate the intervention into their practices. We will rigorously test the effectiveness of the ACTIVE intervention. We will investigate whether the assessment of the informal caregivers perception of pain management will identify those who will benefit most and whether changes in the perceptions of informal caregivers will result in improvement of patient pain. We will explore barriers and challenges in the implementation of this into every day practice within hospice

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Informal Caregiver Inclusion Criteria

  • Informal caregiver of an enrolled hospice patient
  • Age 18 or over and legally able to provide informed consent
  • Involved in decisions related to pain medications
  • Access to at least one of the below:
  • A standard land line telephone
  • A high-speed Internet connection with operational computer
  • Without functional hearing loss or with a hearing aid that allows the participant to conduct phone or Internet conversations as assessed by the research staff (by questioning and observation

-

Exclusion criteria

Informal caregivers of hospice patients with a life expectancy less than 14 days as assessed by the hospice nurse with the palliative performance scale (PPS) (99)

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Treatment and study plan

ACTIVE

Behavioral

Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient

Primary outcomes

  1. Caregiver Perceptions of Pain Medicine Questionaire

    Time frame: Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure

    This 16 question instrument measures the perceptions hospice caregivers have toward the administration of pain medications. Scores on items vary from 1-5 with the lower scores indicating more problematic perceptions of pain management. A Total score is computed between 16-80 Only the last available measure will be used to reflect the measure closest to time of death.

Secondary outcomes

  1. Caregiver Quality of Life-Revised Subscale Emotional

    Time frame: Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure

    This is one domain of a four domain instrument. It involves one question with a range of 0-10.Only the last available measure will be used to reflect the measure closest to time of death.

  2. Anxiety

    Time frame: Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure

    This measure determines the level of anxiety experienced by a hospice caregiver. Total scores range from 0-21 with higher scores representing more anxiety. Only the last available measure will be used to reflect the measure closest to time of death.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Sep 29, 2010
Registry last updated
Feb 4, 2021

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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