Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Developing Accessible mHealth Programs for Depression Management in Bolivia

4. maj 2016 opdateret af: John Piette, University of Michigan
The purpose of the study is to evaluate the feasibility and potential impact of an automated phone system in monitoring and improving self-care and health outcomes among patients with depression in Bolivia.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

All patients will receive a weekly 10-15 minute automated phone call to their cell phone for disease assessment and self-care support for up to 12 weeks. During enrollment, the research team will explain how to use the automated phone system. During patients' automated calls, they will be asked questions about their self-care relevant to their diagnosis, symptoms of depression, and medication adherence (if patients are prescribed an anti-depressant). Based on the patient's self-report, they will receive targeted suggestions for how to improve their self-management. At the end of each automated call, patients will hear the phone number of their clinic, which they can call for a health problem or to disenroll from the program. At the time of recruitment, if possible, an initial automated call will be sent to the patient's phone so that they can learn what to expect and have the chance to ask questions of the research associate who will be present.

In the event that the patient reports a health or self-care problem during their call (i.e., the patient reports rarely or never taking their medication), a report will automatically be generated and sent by email to the research team plus the patient's designated clinician so that follow-up can take place. The secure email address will be verified with each clinician, and be password protected.

The intervention will last up to 12 weeks, after which the patient will have a follow-up meeting with the research team and will complete a survey about the program. All follow-ups will take place either in person or over the phone.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

32

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • La Paz, Bolivia
        • El Servicio Departmental de Salud (SEDES) affiliated clinics

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 21-80 years of age
  • PHQ-8 score of 10 or higher

Exclusion Criteria:

  • Have diagnoses indicating a six-month life expectancy
  • Prior inpatient psychiatric treatment
  • Patients with probable bipolar disorder or cognitive impairment as indicated on validated screeners

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Automated phone calls
Automated disease assessment & self-care support phone calls for up to 12 weeks.
Automated disease assessment & self-care support phone calls for up to 12 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change from baseline on depressive symptoms at 12 weeks (PHQ-8 Scores)
Tidsramme: Baseline and 12 week post-intervention follow-up
Baseline and 12 week post-intervention follow-up

Sekundære resultatmål

Resultatmål
Tidsramme
Change from baseline on self-care behaviors at 12 weeks (self-care behavior questionnaire)
Tidsramme: Baseline and 12 week post-intervention follow-up
Baseline and 12 week post-intervention follow-up
Evaluate program feasibility (telephone call completion rates)
Tidsramme: 12 week post-intervention follow-up
12 week post-intervention follow-up
Patient satisfaction (satisfaction questionnaire)
Tidsramme: 12 week Post-intervention follow-up
12 week Post-intervention follow-up
Patient qualitative feedback (qualitative questionnaire)
Tidsramme: 12 week Post-intervention follow-up
12 week Post-intervention follow-up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: John D Piette, PhD, University of Michigan

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2014

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

4. marts 2015

Først indsendt, der opfyldte QC-kriterier

4. maj 2016

Først opslået (Skøn)

6. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. maj 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2016

Sidst verificeret

1. maj 2016

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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 .

Abonner