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PainNCT01211340

The ACTIVE Intervention to Improve Hospice Care

A study testing ACTIVE in people with Pain, run by Washington University School of Medicine at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Pain
What is being tested?
ACTIVE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
446 participants
Where
2 sitesUnited States
Study dates
Sep 2010to Jul 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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)
  • -

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Hospice Compassus

    Columbia, Missouri, 65203

  • Hands of Hope Hospice

    Saint Joseph, Missouri, 65203

Other trials in United States

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 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.

Read the 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

Conditions
Pain
Being tested
ACTIVE
Keywords
Hospice, Caregivers, Interdisciplinary Team, Pain management
Medical subject headings
Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACTIVEBehavioural

    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

Study groups in NCT01211340
Study groupRoleWhat they receive
Usual CareNo interventionUsual hospice care- there is no intervention in this arm
ACTIVEExperimentalBehavioral intervention using web conferencing
Receives: Behavioral: ACTIVE

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Caregiver Quality of Life-Revised Subscale Emotional

    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.

    Measured: 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

  2. Anxiety

    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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionApr 2014
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
446 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01211340
Sponsor's protocol ID
1160518
Status last verified
Apr 2017
First submitted
23 Sep 2010
Last updated
4 Feb 2021
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 23104974

  • 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.

    PubMed 27465403

  • 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.

    PubMed 24524662

  • 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.

    PubMed 24295096

  • 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.

    PubMed 24246789

  • 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.

    PubMed 23937064

  • 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.

    PubMed 23558847

  • 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.

    PubMed 23522518

  • 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.

    PubMed 23233538

  • 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.

    PubMed 23036014

Questions about this trial

What is this clinical trial studying?

A study testing ACTIVE in people with Pain, run by Washington University School of Medicine at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01211340, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.

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