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The ACTIVE Intervention to Improve Hospice Care

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01211340
First Posted: September 29, 2010
Last Update Posted: June 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Debra Parker Oliver, PhD, MSW, University of Missouri-Columbia
  Purpose
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.

Condition Intervention
Pain Behavioral: ACTIVE

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The ACTIVE Intervention to Improve Hospice Care

Resource links provided by NLM:


Further study details as provided by Debra Parker Oliver, PhD, MSW, University of Missouri-Columbia:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.


Enrollment: 446
Study Start Date: September 2010
Study Completion Date: July 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
Usual hospice care- there is no intervention in this arm
Experimental: ACTIVE
Behavioral intervention using web conferencing
Behavioral: ACTIVE
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

Detailed Description:
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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Informal Caregiver Inclusion Criteria

  1. Informal caregiver of an enrolled hospice patient
  2. Age 18 or over and legally able to provide informed consent
  3. Involved in decisions related to pain medications
  4. Access to at least one of the below:

    1. A standard land line telephone
    2. A high-speed Internet connection with operational computer
  5. 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)

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01211340


Locations
United States, Missouri
Hospice Compassus
Columbia, Missouri, United States, 65203
Hands of Hope Hospice
St Joseph, Missouri, United States, 65203
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Debra Parker Oliver, PhD University of Missouri-Columbia
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Debra Parker Oliver, PhD, MSW, Principle Investigator, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01211340     History of Changes
Other Study ID Numbers: 1160518
First Submitted: September 23, 2010
First Posted: September 29, 2010
Results First Submitted: September 2, 2015
Results First Posted: June 20, 2017
Last Update Posted: June 20, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Debra Parker Oliver, PhD, MSW, University of Missouri-Columbia:
Hospice
Caregivers
Interdisciplinary Team
Pain management