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Training Doctors to Support Patient Self-Care of Depression

30. November 2015 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

182

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • California
      • Sacramento, California, Vereinigte Staaten, 95817
        • University of California Davis Health System
      • Sacramento, California, Vereinigte Staaten, 95816
        • Sutter Health Sacramento

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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
Verhalten: 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
Aktiver Komparator: Control (knowledge enhancement)
Brief video clip designed to increase primary care physician awareness of new medication treatments for patients with diabetes
Sonstiges: Knowledge enhancement
Brief video clip designed to increase primary care physician awareness of new medication treatments for diabetes

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Physician use of self-efficacy enhancing interviewing techniques
Zeitfenster: During the 3 months after receiving intervention
During the 3 months after receiving intervention

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Patient self-efficacy for depression self-care
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 5 minutes after an index visit with primary provider
5 minutes after an index visit with primary provider
Patient depressive symptoms
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of California, Davis

Mitarbeiter

National Institute of Mental Health (NIMH)

Ermittler

  • Hauptermittler: Anthony Jerant, MD, University of California, Davis

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. April 2013

Primärer Abschluss (Tatsächlich)

1. Februar 2015

Studienabschluss (Tatsächlich)

1. Mai 2015

Studienanmeldedaten

Zuerst eingereicht

8. Mai 2012

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. Juni 2012

Zuerst gepostet (Schätzen)

13. Juni 2012

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

2. Dezember 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. November 2015

Zuletzt verifiziert

1. November 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2012336397-1
  • R34MH095893 (US NIH Stipendium/Vertrag)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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