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Training Doctors to Support Patient Self-Care of Depression

30. listopadu 2015 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

182

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • California
      • Sacramento, California, Spojené státy, 95817
        • University of California Davis Health System
      • Sacramento, California, Spojené státy, 95816
        • Sutter Health Sacramento

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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
Behaviorální: 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
Aktivní komparátor: Control (knowledge enhancement)
Brief video clip designed to increase primary care physician awareness of new medication treatments for patients with diabetes
Jiný: Knowledge enhancement
Brief video clip designed to increase primary care physician awareness of new medication treatments for diabetes

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Časové okno
Physician use of self-efficacy enhancing interviewing techniques
Časové okno: During the 3 months after receiving intervention
During the 3 months after receiving intervention

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Patient self-efficacy for depression self-care
Časové okno: 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
Časové okno: 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)
Časové okno: 5 minutes after an index visit with primary provider
5 minutes after an index visit with primary provider
Patient depressive symptoms
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of California, Davis

Spolupracovníci

National Institute of Mental Health (NIMH)

Vyšetřovatelé

  • Vrchní vyšetřovatel: Anthony Jerant, MD, University of California, Davis

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. dubna 2013

Primární dokončení (Aktuální)

1. února 2015

Dokončení studie (Aktuální)

1. května 2015

Termíny zápisu do studia

První předloženo

8. května 2012

První předloženo, které splnilo kritéria kontroly kvality

11. června 2012

První zveřejněno (Odhad)

13. června 2012

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

2. prosince 2015

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

30. listopadu 2015

Naposledy ověřeno

1. listopadu 2015

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 2012336397-1
  • R34MH095893 (Grant/smlouva NIH USA)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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