Depression and Congestive Heart Failure in Outpatients.
Depression and CHF in Outpatients
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Iowa
-
Iowa City, Iowa, États-Unis, 52246
- Iowa City VA Medical Center
-
-
Missouri
-
Columbia, Missouri, États-Unis, 65201-5297
- Harry S. Truman Memorial VA Medical Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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
|
|
Expérimental: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Beck Depression Inventory II
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Health-Related Quality of Life
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Carolyn L Turvey, PhD MS, VA Medical Center, Iowa City
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IIR 06-082
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .