- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01211340
The ACTIVE Intervention to Improve Hospice Care
Studieoversigt
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Missouri
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Columbia, Missouri, Forenede Stater, 65203
- Hospice Compassus
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Saint Joseph, Missouri, Forenede Stater, 65203
- Hands of Hope Hospice
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
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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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Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: Usual Care
Usual hospice care- there is no intervention in this arm
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Eksperimentel: ACTIVE
Behavioral intervention using web conferencing
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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
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Caregiver Perceptions of Pain Medicine Questionaire
Tidsramme: 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
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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.
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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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Caregiver Quality of Life-Revised Subscale Emotional
Tidsramme: 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
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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.
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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
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Anxiety
Tidsramme: 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
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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.
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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
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Debra Parker Oliver, PhD, University of Missouri-Columbia
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 1160518
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med Smerte
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Istanbul University - CerrahpasaRekrutteringPatellofemoral Pain, PfpTyrkiet (Türkiye)
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Pamukkale UniversityIkke rekrutterer endnuPatellofemoral Pain, PfpTyrkiet (Türkiye)
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Beijing Sport UniversityAfsluttetPatellofemoral Pain, PfpKina
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Beijing Sport UniversityIkke rekrutterer endnuPatellofemoral Pain, Pfp
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Beijing Sport UniversityIkke rekrutterer endnu
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Sahmyook UniversityAfsluttetMyofascial Pain Syndrome (MPS)Sydkorea
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Future University in EgyptAfsluttet
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Camilo Jose Cela UniversityAfsluttetMyofascial Pain Syndrome (MPS)Spanien
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Izmir Tinaztepe UniversityEge UniversityIkke rekrutterer endnuRygliggende stilling | FLACC Skala | Behavioral Pain Scale
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University of California, DavisNational Institutes of Health (NIH); National Center for Complementary...Ikke rekrutterer endnuKronisk lænderygsmerter (cLBP) | Myofascial Pain Syndrome (MPS)Forenede Stater
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