NCT01211340

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
446

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2010

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
2 years until next milestone

Results Posted

Study results publicly available

June 20, 2017

Completed
Last Updated

February 4, 2021

Status Verified

April 1, 2017

Enrollment Period

3.6 years

First QC Date

September 23, 2010

Results QC Date

September 2, 2015

Last Update Submit

January 15, 2021

Conditions

Keywords

HospiceCaregiversInterdisciplinary TeamPain management

Outcome Measures

Primary Outcomes (1)

  • Caregiver Perceptions of Pain Medicine Questionaire

    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.

    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

Secondary Outcomes (2)

  • Caregiver Quality of Life-Revised Subscale Emotional

    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

  • Anxiety

    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

Study Arms (2)

Usual Care

NO INTERVENTION

Usual hospice care- there is no intervention in this arm

ACTIVE

EXPERIMENTAL

Behavioral intervention using web conferencing

Behavioral: ACTIVE

Interventions

ACTIVEBEHAVIORAL

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

ACTIVE

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospice Compassus

Columbia, Missouri, 65203, United States

Location

Hands of Hope Hospice

Saint Joseph, Missouri, 65203, United States

Location

Related Publications (10)

  • Kruse RL, Parker Oliver D, Wittenberg-Lyles E, Demiris G. Conducting the ACTIVE randomized trial in hospice care: keys to success. Clin Trials. 2013 Feb;10(1):160-9. doi: 10.1177/1740774512461858. Epub 2012 Oct 25.

    PMID: 23104974BACKGROUND
  • Parker Oliver D, Demiris G, Washington K, Kruse RL, Petroski G. Hospice Family Caregiver Involvement in Care Plan Meetings: A Mixed-Methods Randomized Controlled Trial. Am J Hosp Palliat Care. 2017 Nov;34(9):849-859. doi: 10.1177/1049909116661816. Epub 2016 Jul 27.

  • Washington KT, Demiris G, Pike KC, Kruse RL, Oliver DP. Anxiety among informal hospice caregivers: an exploratory study. Palliat Support Care. 2015 Jun;13(3):567-73. doi: 10.1017/S1478951513001193. Epub 2014 Feb 13.

  • Parker Oliver D, Albright DL, Washington K, Wittenberg-Lyles E, Gage A, Mooney M, Demiris G. Hospice caregiver depression: the evidence surrounding the greatest pain of all. J Soc Work End Life Palliat Care. 2013;9(4):256-71. doi: 10.1080/15524256.2013.846891.

  • Albright DL, Kruse RL, Oliver DP, Washington K, Cagle J, Demiris G. Testing the factorial validity of scores from the caregiver pain medicine questionnaire. J Pain Symptom Manage. 2014 Jul;48(1):99-109. doi: 10.1016/j.jpainsymman.2013.08.014. Epub 2013 Nov 15.

  • Wittenberg-Lyles E, Goldsmith J, Oliver DP, Demiris G, Kruse RL, Van Stee S. Using medical words with family caregivers. J Palliat Med. 2013 Sep;16(9):1135-9. doi: 10.1089/jpm.2013.0041. Epub 2013 Aug 12.

  • Demiris G, Parker Oliver D, Capurro D, Wittenberg-Lyles E. Implementation science: implications for intervention research in hospice and palliative care. Gerontologist. 2014 Apr;54(2):163-71. doi: 10.1093/geront/gnt022. Epub 2013 Apr 4.

  • Wittenberg-Lyles E, Goldsmith J, Oliver DP, Demiris G, Kruse RL, Van Stee S. Exploring oral literacy in communication with hospice caregivers. J Pain Symptom Manage. 2013 Nov;46(5):731-6. doi: 10.1016/j.jpainsymman.2012.11.006. Epub 2013 Mar 21.

  • Baldwin PK, Wittenberg-Lyles E, Kruse RL, Demiris G, Parker Oliver D. Pain management and the African American hospice caregiver: a case report. Am J Hosp Palliat Care. 2013 Dec;30(8):795-8. doi: 10.1177/1049909112469274. Epub 2012 Dec 10. No abstract available.

  • Washington KT, Wittenberg-Lyles E, Parker Oliver D, Demiris G, Shaunfield S, Crumb E. Application of the VALUE communication principles in ACTIVE hospice team meetings. J Palliat Med. 2013 Jan;16(1):60-6. doi: 10.1089/jpm.2012.0229. Epub 2012 Oct 4.

MeSH Terms

Conditions

PainAgnosia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Debra Parker Oliver
Organization
University of Missouri

Study Officials

  • Debra Parker Oliver, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 23, 2010

First Posted

September 29, 2010

Study Start

September 1, 2010

Primary Completion

April 1, 2014

Study Completion

July 1, 2015

Last Updated

February 4, 2021

Results First Posted

June 20, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations