- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02765542
Developing Accessible mHealth Programs for Depression Management in Bolivia
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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La Paz, Bolivia
- El Servicio Departmental de Salud (SEDES) affiliated clinics
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Automated phone calls
Automated disease assessment & self-care support phone calls for up to 12 weeks.
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Automated disease assessment & self-care support phone calls for up to 12 weeks.
|
Hva måler studien?
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
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Baseline and 12 week post-intervention follow-up
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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
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12 week Post-intervention follow-up
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: John D Piette, PhD, University of Michigan
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HUM00087937
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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