- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00321269
Depression and Congestive Heart Failure in Outpatients.
Depression and CHF in Outpatients
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Background:
Between 4 and 5% of patients seen at Veterans Affairs Medical Centers suffer heart failure. HF is the number one discharge diagnosis within the VHA. One of the most significant comorbidities in heart failure is depression. Depression predicts increased hospitalization and mortality even after controlling for key prognostic indicators. This HSR&D study aimed to test the effectiveness of a psychotherapy intervention for depression combined with illness management to illness management alone in veterans with heart failure.
Objectives:
To demonstrate better depression, health-related quality-of-life, and adherence outcomes for an illness management combined with psychotherapy intervention (COMBO) as compared to an illness management alone program (IMO).
Methods:
This was a two-site, two-arm, randomized controlled trial comparing COMBO to IMO. The total number of patients recruited for the study was 148. Retention was comparable between groups, though depression severity predicted drop out in the IMO condition but not the COMBO condition. Patients completed study assessments at baseline, week 4, week 8 (post-intervention) and at 26- and 52-week follow-up.
Status:
The main study analyses have been conducted. The project team is conducting analysis of secondary hypotheses
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Iowa
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Iowa City, Iowa, Forenede Stater, 52246
- Iowa City VA Medical Center
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Missouri
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Columbia, Missouri, Forenede Stater, 65201-5297
- Harry S. Truman Memorial VA Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Receiving treatment for NYHA Class 2-4 heart failure.
- Patients of the Iowa City, IA or Columbia, MO Veterans Affairs Medical Center Primary Care or Cardiac Care Clinics.
- Life expectancy greater than 6 months.
- Must speak English.
- Must possess a working telephone.
Exclusion Criteria:
- Presence of major psychiatric illness such as schizophrenia, bipolar disorder and substance abuse (PTSD patients are eligible).
- Life expectancy less than 3 months.
- Planned relocation to a nursing home.
- Marked visual or hearing impairment.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Single Illness Managment
This intervention includes standard disease self-management coaching for heart failure and helps patients set goals for fluid management, restricted salt-intake, and medication adherence.
|
8 week nursing intervention addressing Congestive Heart Failure
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Eksperimentel: Comorbid Illness Management
This intervention includes the same self-management coaching found in the comparator arm, but also includes discussion of ways to cope and manage mood.
|
8 week nursing intervention to address Congestive Heart Failure and emotional coping
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Beck Depression Inventory II
Tidsramme: Depression and psychological health will be assessed at week 1, week 8
|
Depressive Symptoms measured on a Beck Depression Inventory Revised Possible Range 0 to 63.
Higher scores indicate greater depression.
Effectiveness of treatment indicated by a decline in the BDI-II score.
|
Depression and psychological health will be assessed at week 1, week 8
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Health-Related Quality of Life
Tidsramme: Measured at week 1, week 8
|
Medical Outcomes Study SF-36 Physical Function Subscale- 10 Items Range 0 to 100, Higher Scores indicate higher functioning.
|
Measured at week 1, week 8
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Carolyn L Turvey, PhD MS, VA Medical Center, Iowa City
Publikationer og nyttige links
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 (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IIR 06-082
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 .
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