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Training Doctors to Support Patient Self-Care of Depression

30 novembre 2015 mis à jour par: University of California, Davis

Physician Training to Support Patient Self-Efficacy for Depression Care Behaviors

This study will determine whether practicing primary care providers (PCPs) can be trained to support patient self-care of depression and co-existing diabetes during office visits, and begin to explore whether this might improve depression and diabetes outcomes, and whether the effects of the training generalize to patients with health conditions other than depression and diabetes. This is important because most patients with chronic conditions struggle with self-care and are seen in primary care, yet PCPs are seldom trained to support self-care.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Many primary care patients struggle with health behaviors that can reduce depressive symptoms, such as adhering to prescribed treatments. Bolstering patient self-efficacy can improve health behaviors and outcomes, including those related to depression. However, current self-efficacy interventions are provided outside of primary care, and so cannot harness the power of therapeutic primary care provider (PCP)-patient relationships. Teaching PCPs to employ self-efficacy enhancing interviewing techniques (SEE IT) with patients would build upon existing therapeutic relationships, greatly increasing the reach of self-efficacy enhancement. The randomized controlled trial (RCT) in this proposal will examine whether, as compared with an attention control condition, a brief (< 1 hour) office-based intervention for practicing PCPs will lead to significantly greater use of SEE IT during unannounced follow-up SP encounters (postintervention and 3 months). The interventions will be delivered to PCPs during their regular office hours by standardized patient (SP) instructors. All study SPs will portray patients with both depression and diabetes, since these conditions commonly co-occur and entail a heavy burden of health-enhancing behaviors. Exploratory (due to limited statistical power) analyses will explore intervention effects on the following outcomes among real patients with co-occurring depression and diabetes: self-efficacy for depression and diabetes self-care, actual self-care behaviors (e.g. medication adherence), symptom severity, and health status. Further exploratory (due to limited statistical power) analyses will explore intervention effects on the following outcomes among real patients with various chronic conditions (ie, not limited to depression and diabetes): self-care self-efficacy, actual self-care behaviors, symptom severity, and health status. Pre- and post-RCT focus groups with stakeholders (PCPs, office staff, patients, and SP instructors) will guide refinement of the SEE IT intervention. The proposed research activities will inform the design (e.g. sample size) and conduct of a future R01-funded, multi-center, cluster RCT of the finalized intervention, adequately powered to examine effects on a range of patient outcomes; sustainability of effects on PCP interviewing over time; and generalizability to other practice settings and common co-morbid mental health and physical illness clusters. The SEE IT intervention begins to address the broader health needs of individuals with depression in primary care, and has unique potential to reduce the tremendous burden of mental illness related morbidity and mortality.

Type d'étude

Interventionnel

Inscription (Réel)

182

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • California
      • Sacramento, California, États-Unis, 95817
        • University of California Davis Health System
      • Sacramento, California, États-Unis, 95816
        • Sutter Health Sacramento

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria: Physicians (targeted enrollment=56; actual enrollment=50)

  • Currently in practice at a participating office within one of the 2 participating health systems (University of California Davis Primary Care Network, Sutter Sacramento Health System)
  • Trained as a family physician, general practitioner, and/or general internist
  • Able to read and speak English

Inclusion Criteria: Group of patients with diabetes and depressive symptoms (targeted enrollment=168; actual enrollment=15)

  • Receive primary health care in one of the participating offices, from one of the participating primary care physicians
  • Aged 18 years or older
  • Able to read and speak English
  • Self-report of adequate vision, hearing, and hand function to complete self-administered questionnaires on a touch screen notebook computer
  • Have concurrent diagnoses of depression and diabetes, determined via medical record review
  • Have at least mild depressive symptoms, manifested by a score of 10 or greater on a telephone-administered Patient Health Questionnaire (PHQ-9).
  • Have an office visit scheduled with their assigned primary care provider within 1 month of study eligibility screening
  • Made 2 or more of their primary care office visits during the preceding year with their assigned primary care provider

Inclusion Criteria: Group of patients with various health conditions, ie, not limited to diabetes and depression (targeted enrollment=336; actual enrollment=117)

  • Receive primary health care in one of the participating offices, from one of the participating primary care physicians
  • Aged 18 years or older
  • Able to read and speak English
  • Self-report of adequate vision, hearing, and hand function to complete self-administered questionnaires on a touch screen notebook computer
  • Have an office visit scheduled with their assigned primary care provider within 1 month of study eligibility screening
  • Made 2 or more of their primary care office visits during the preceding year with their assigned primary care provider

Exclusion Criteria: Patients (applies to all study patients)

  • Self-report or medical record evidence of unstable overall medical status
  • Self-report or medical record evidence of terminal illness
  • Self-report or medical record evidence of bipolar disorder, chronic psychosis (schizophrenia or other), or personality disorder
  • Self-report or medical record evidence of a history of attempted suicide
  • Planned transfer of care to a health system other than the 2 participating systems within 6 months
  • Inability to understand any of the screening questions, after appropriate explanation (e.g. due to cognitive impairment, developmental delay, or other reasons)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: SEE IT training (interviewing skills)
Intervention to train primary care physicians in the use of self-efficacy enhancing interviewing techniques (SEE IT) with patients who have coexisting depression and diabetes
Comportemental: SEE IT training
Standardized patient instructors provide a scripted intervention to train primary care physicians in the use of self-efficacy enhancing interviewing techniques (SEE IT) during office visits with patients who have coexisting depression and diabetes
Comparateur actif: Control (knowledge enhancement)
Brief video clip designed to increase primary care physician awareness of new medication treatments for patients with diabetes
Autre: Knowledge enhancement
Brief video clip designed to increase primary care physician awareness of new medication treatments for diabetes

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Physician use of self-efficacy enhancing interviewing techniques
Délai: During the 3 months after receiving intervention
During the 3 months after receiving intervention

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Patient self-efficacy for depression self-care
Délai: 5 minutes after an index visit with primary provider
5 minutes after an index visit with primary provider
Patient self-efficacy for diabetes self-care
Délai: 5 minutes after an index visit with primary provider
5 minutes after an index visit with primary provider
General self-care self-efficacy (all health conditions)
Délai: 5 minutes after an index visit with primary provider
5 minutes after an index visit with primary provider
Patient depressive symptoms
Délai: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient depression self-care behaviors
Délai: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient diabetes self-care behaviors
Délai: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient chronic illness self-care behaviors (generic)
Délai: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient adherence to depression and diabetes medications
Délai: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient adherence to chronic illness medications (generic)
Délai: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient adherence to depression counseling
Délai: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient mental health status
Délai: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient physical health status
Délai: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Patient glycemic control
Délai: 3 months after an index visit with their primary care provider
3 months after an index visit with their primary care provider
Wallston Multidimensional Health Locus of Control Scale
Délai: 5 minutes after an index visit with their primary care provider
Perceived control over health
5 minutes after an index visit with their primary care provider
Healthcare Climate Questionnaire
Délai: 5 minutes after an index visit with their primary care provider
Patient perception of degree to which primary care provider is autonomy supportive
5 minutes after an index visit with their primary care provider

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of California, Davis

Collaborateurs

National Institute of Mental Health (NIMH)

Les enquêteurs

  • Chercheur principal: Anthony Jerant, MD, University of California, Davis

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2013

Achèvement primaire (Réel)

1 février 2015

Achèvement de l'étude (Réel)

1 mai 2015

Dates d'inscription aux études

Première soumission

8 mai 2012

Première soumission répondant aux critères de contrôle qualité

11 juin 2012

Première publication (Estimation)

13 juin 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

2 décembre 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 novembre 2015

Dernière vérification

1 novembre 2015

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2012336397-1
  • R34MH095893 (Subvention/contrat des NIH des États-Unis)

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 .

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