- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01444027
Hospice Problem Solving Intervention
17 november 2017 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
514
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Washington
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Seattle, Washington, Förenta staterna, 98195
- University of Washington
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Inget ingripande: 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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Experimentell: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Caregiver Anxiety: Change From Baseline to Post-Intervention Exit
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: George Demiris, PhD, University of Washington
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 2011
Primärt slutförande (Faktisk)
1 mars 2016
Avslutad studie (Faktisk)
1 mars 2016
Studieregistreringsdatum
Först inskickad
28 september 2011
Först inskickad som uppfyllde QC-kriterierna
29 september 2011
Första postat (Uppskatta)
30 september 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 december 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 november 2017
Senast verifierad
1 november 2017
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 36909
- 1R01NR012213-01A1 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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