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Hospice Problem Solving Intervention

17. november 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

514

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Washington
      • Seattle, Washington, Forenede Stater, 98195
        • University of Washington

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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
Ingen indgriben: Attention Control
This group receives standard care with the attention of social support/ "friendly interactions" and serves as an attention control group.
Eksperimentel: Intervention Group 1 (Face to Face)
This group receives Problem Solving Therapy in face to face visits.
Adfærdsmæssigt: Problem Solving Therapy
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.
Eksperimentel: Intervention Group 2 (Video)
This group receives Problem Solving Therapy via video.
Adfærdsmæssigt: Problem Solving Therapy
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Caregiver Anxiety: Change From Baseline to Post-Intervention Exit
Tidsramme: At Baseline and Exit (approximately 4 weeks after recruitment)
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.
At Baseline and Exit (approximately 4 weeks after recruitment)
Caregiver Quality of Life - Physical: Change From Baseline to Post-Intervention Exit
Tidsramme: At Baseline and Exit (approximately 4 weeks after recruitment)
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.
At Baseline and Exit (approximately 4 weeks after recruitment)
Caregiver Quality of Life - Social: Change From Baseline to Post-Intervention Exit
Tidsramme: At Baseline and Exit (approximately 4 weeks after recruitment)
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.
At Baseline and Exit (approximately 4 weeks after recruitment)
Caregiver Quality of Life - Emotional: Change From Baseline to Post-Intervention Exit
Tidsramme: At Baseline and Exit (approximately 4 weeks after recruitment)
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.
At Baseline and Exit (approximately 4 weeks after recruitment)
Caregiver Quality of Life - Financial: Change From Baseline to Post-Intervention Exit
Tidsramme: At Baseline and Exit (approximately 4 weeks after recruitment)
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.
At Baseline and Exit (approximately 4 weeks after recruitment)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Washington

Samarbejdspartnere

National Institute of Nursing Research (NINR)

Efterforskere

  • Ledende efterforsker: George Demiris, PhD, University of Washington

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2011

Primær færdiggørelse (Faktiske)

1. marts 2016

Studieafslutning (Faktiske)

1. marts 2016

Datoer for studieregistrering

Først indsendt

28. september 2011

Først indsendt, der opfyldte QC-kriterier

29. september 2011

Først opslået (Skøn)

30. september 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. december 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. november 2017

Sidst verificeret

1. november 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 36909
  • 1R01NR012213-01A1 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Problem Solving Therapy

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

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Betingelser

Sjældne sygdomme

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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