Hospice Problem Solving Intervention
17. listopadu 2017 aktualizováno: George Demiris, University of Washington
A Problem Solving Intervention for Hospice Caregivers
In recent years, the demand for home hospice care has grown rapidly.
Family members and friends who act as informal caregivers are essential to the provision of palliative care services; however, this role is not without adverse effects on the caregivers themselves.
It is well documented that emotional needs of individuals caring for dying persons in their home are not well attended, and interventions aiming to provide support to informal hospice caregivers are notably lacking.
In this context, problem solving therapy (PST) provides an overall coping process that fosters adaptive situational coping and behavioral competence.
The investigators are conducting a randomized controlled trial to fully evaluate the PST intervention for informal hospice caregivers.
Additionally, the investigators aim to evaluate how the modality of the intervention (face to face vs video) impacts its effectiveness.
This investigator team is conducting a 4-year randomized trial study in which hospice caregivers will be randomly assigned to a group receiving standard hospice care with the addition of social support interactions (attention control group) or a group receiving standard hospice care with the addition of the problem solving intervention delivered face to face (intervention group 1) or a group receiving standard hospice care with the addition of the problem solving intervention delivered via video (intervention group 2).
The specific aims include an assessment of the impact of PST on caregiver quality of life, problem solving ability, and caregiver anxiety.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
514
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Washington
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Seattle, Washington, Spojené státy, 98195
- University of Washington
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- enrolled as a family/informal caregiver of a hospice patient
- 18 years or older
- with access to a standard phone line or Internet and computer access at home
- without functional hearing loss or with a hearing aid that allows the participant to conduct telephone conversations as assessed by the research staff (by questioning and observing the caregiver)
- no or only mild cognitive impairment
- speak and read English, with at least a 6th-grade education
Exclusion Criteria:
- lack of phone or Internet access
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Žádný zásah: Attention Control
This group receives standard care with the attention of social support/ "friendly interactions" and serves as an attention control group.
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Experimentální: Intervention Group 1 (Face to Face)
This group receives Problem Solving Therapy in face to face visits.
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Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework.
PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation.
The intervention is delivered in a series of interactions with the interventionist.
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Experimentální: Intervention Group 2 (Video)
This group receives Problem Solving Therapy via video.
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Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework.
PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation.
The intervention is delivered in a series of interactions with the interventionist.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Caregiver Anxiety: Change From Baseline to Post-Intervention Exit
Časové okno: At Baseline and Exit (approximately 4 weeks after recruitment)
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Caregiver anxiety was measured with the 7-item Generalized Anxiety Disorder (GAD-7) Scale (Spitzer et al., 2006), which measures the frequency with which respondents experience symptoms of anxiety such as restlessness, difficulty relaxing, and uncontrollable worrying.
The GAD-7 total scores range from 0 to 21, with higher scores indicating more anxiety.
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At Baseline and Exit (approximately 4 weeks after recruitment)
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Caregiver Quality of Life - Physical: Change From Baseline to Post-Intervention Exit
Časové okno: At Baseline and Exit (approximately 4 weeks after recruitment)
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An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale.
Higher scores indicate better physical quality of life.
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At Baseline and Exit (approximately 4 weeks after recruitment)
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Caregiver Quality of Life - Social: Change From Baseline to Post-Intervention Exit
Časové okno: At Baseline and Exit (approximately 4 weeks after recruitment)
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An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale.
Higher scores indicate better social quality of life.
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At Baseline and Exit (approximately 4 weeks after recruitment)
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Caregiver Quality of Life - Emotional: Change From Baseline to Post-Intervention Exit
Časové okno: At Baseline and Exit (approximately 4 weeks after recruitment)
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An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale.
Higher scores indicate better emotional quality of life.
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At Baseline and Exit (approximately 4 weeks after recruitment)
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Caregiver Quality of Life - Financial: Change From Baseline to Post-Intervention Exit
Časové okno: At Baseline and Exit (approximately 4 weeks after recruitment)
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An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale.
Higher scores indicate better financial quality of life.
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At Baseline and Exit (approximately 4 weeks after recruitment)
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: George Demiris, PhD, University of Washington
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Starr LT, Bullock K, Washington K, Aryal S, Parker Oliver D, Demiris G. Anxiety, Depression, Quality of Life, Caregiver Burden, and Perceptions of Caregiver-Centered Communication among Black and White Hospice Family Caregivers. J Palliat Med. 2022 Apr;25(4):596-605. doi: 10.1089/jpm.2021.0302. Epub 2021 Nov 18.
- Demiris G, Oliver DP, Washington K, Pike K. A Problem-Solving Intervention for Hospice Family Caregivers: A Randomized Clinical Trial. J Am Geriatr Soc. 2019 Jul;67(7):1345-1352. doi: 10.1111/jgs.15894. Epub 2019 Apr 4.
- Benson JJ, Parker Oliver D, Demiris G, Washington K. Accounts of Family Conflict in Home Hospice Care: The Central Role of Autonomy for Informal Caregiver Resilience. J Fam Nurs. 2019 May;25(2):190-218. doi: 10.1177/1074840719828091. Epub 2019 Feb 17.
- Tarter R, Demiris G, Pike K, Washington K, Parker Oliver D. Pain in Hospice Patients With Dementia: The Informal Caregiver Experience. Am J Alzheimers Dis Other Demen. 2016 Sep;31(6):524-9. doi: 10.1177/1533317516653825. Epub 2016 Jun 14.
- Oliver DP, Demiris G, Washington KT, Clark C, Thomas-Jones D. Challenges and Strategies for Hospice Caregivers: A Qualitative Analysis. Gerontologist. 2017 Aug 1;57(4):648-656. doi: 10.1093/geront/gnw054.
- Washington KT, Pike KC, Demiris G, Parker Oliver D, Albright DL, Lewis AM. Gender Differences in Caregiving at End of Life: Implications for Hospice Teams. J Palliat Med. 2015 Dec;18(12):1048-53. doi: 10.1089/jpm.2015.0214. Epub 2015 Oct 20.
- Washington KT, Pike KC, Demiris G, Oliver DP. Unique characteristics of informal hospice cancer caregiving. Support Care Cancer. 2015 Jul;23(7):2121-8. doi: 10.1007/s00520-014-2570-z. Epub 2014 Dec 30.
- Washington KT, Wittenberg-Lyles E, Oliver DP, Baldwin PK, Tappana J, Wright JH, Demiris G. Rethinking family caregiving: tailoring cognitive-behavioral therapies to the hospice experience. Health Soc Work. 2014 Nov;39(4):244-50. doi: 10.1093/hsw/hlu031.
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. října 2011
Primární dokončení (Aktuální)
1. března 2016
Dokončení studie (Aktuální)
1. března 2016
Termíny zápisu do studia
První předloženo
28. září 2011
První předloženo, které splnilo kritéria kontroly kvality
29. září 2011
První zveřejněno (Odhad)
30. září 2011
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
13. prosince 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
17. listopadu 2017
Naposledy ověřeno
1. listopadu 2017
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 36909
- 1R01NR012213-01A1 (Grant/smlouva NIH USA)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .