Effects of a Phone Call Intervention to Promote HAART Adherence (EPCIPHA)
15. juli 2011 oppdatert av: Baoshan Prefecture Center for Disease Control and Prevention
Effects of a Phone Call Intervention to Promote HAART Adherence in Baoshan, China
The adherence rate (95%) to HAART in the intervention group which receives a phone call will be higher than that(75%)of control group which does not receive a phone call.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
According to above eligibility criteria, getting two eligible group patients, one which are patients newly required HAART (new cases) and the other who have received HAART for 1-3 years(old cases).
All eligible patients in each group will be randomly assigned to intervention and control group by block randomization.
Among of them, one group with a phone call intervention, the other without.
New cases will be followed up for 3 months and study outcomes will be assessed at the baseline and the 2nd week, the 1st month and 2nd month, and the 3rd month.
For the old cases, study outcomes will be assessed only at the baseline survey and at the 3rd month.
Studietype
Intervensjonell
Registrering (Forventet)
300
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Yunnan
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Baoshan, Yunnan, Kina, 67000
- Rekruttering
- Longling county hospital
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Ta kontakt med:
- Chunyan Zhang, Bachelor
- Telefonnummer: 86-0875-6122353
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Hovedetterforsker:
- Dongsheng Huang, Master
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Baoshan, Yunnan, Kina, 678000
- Rekruttering
- Longyang district hospital
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Hovedetterforsker:
- Dongsheng Huang, Master
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Ta kontakt med:
- Junmei Duan, Bachelor
- Telefonnummer: 86-0875-2130187
- E-post: 892991901@qq.com
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Baoshan, Yunnan, Kina, 678000
- Rekruttering
- Tengchong county hospital
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Hovedetterforsker:
- Dongsheng Huang, Master
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Ta kontakt med:
- Tao Jiang, Bachelor
- Telefonnummer: 86-0875-5137151
- E-post: jt4766@sina.com
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Baoshan, Yunnan, Kina, 67800
- Rekruttering
- The first hospital of Baoshan Prefecture
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Hovedetterforsker:
- Dongsheng Huang, Master
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Ta kontakt med:
- Yikun Hu, Bachelor
- Telefonnummer: 86-0875-2120370
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion criteria:
- Chinese patients with HIV/AIDS aged ≥ 18 years and for the newly required HAART patients, mainly based on their CD4 < 350 cells/mm3. But irrespective of CD4 cells for old patients who are under treatment for 1-3 years.
Exclusion criteria:
- Patients who have the inability to communicate at the beginning of study and who haven't got opportunistic infection(this item is only for new cases), who are non-Baoshan registered residence, who are foreigners, prisoners and pregnants, who have no mobile phone.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Phone call
New cases and old cases will be randomly categorized into two groups,respectively,one is phone call intervention group, the other is no phone call intervention group.
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Biweekly phone call intervention +routine service will be assigned to intervention group of new cases and old cases.
Only routine service will be assigned to the control group of abovementioned two kind of cases.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline HAART adherence within 3 months
Tidsramme: HAART adherence for new cases will be assessed at the 2nd week, the 1st month and 2nd month, and the 3rd month follow-up. For old cases HAART adherence will be assessed only at the baseline survey and the 3rd month follow-up
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Adherence will be measured at different time points within 3 months follow-up (study period)
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HAART adherence for new cases will be assessed at the 2nd week, the 1st month and 2nd month, and the 3rd month follow-up. For old cases HAART adherence will be assessed only at the baseline survey and the 3rd month follow-up
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline quality of life within 3 months
Tidsramme: Quality of life for new cases will be assessed at the baseline survey and the 2nd week, the 1st month and 2nd month, and the 3rd month. For old cases quality of life will be assessed only at the baseline survey and the end of the 3rd month
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Quality of life will be measured at different time points within 3 months study periods
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Quality of life for new cases will be assessed at the baseline survey and the 2nd week, the 1st month and 2nd month, and the 3rd month. For old cases quality of life will be assessed only at the baseline survey and the end of the 3rd month
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CD4 cell counts
Tidsramme: CD4 will be measured at the baseline survey and the 3rd month follow-up
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CD4 cell counts will be measured only at baseline survey and after 3 months
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CD4 will be measured at the baseline survey and the 3rd month follow-up
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Number of patients with side effects
Tidsramme: Number of side effects for new cases will be assessed at the 2nd week, the 1st month and 2nd month, and the 3rd month follow-up. For old cases the number of side effects will be assessed only at the baseline survey and the 3rd month follow-up
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The number of side effects will be measured at different time points within 3 months follow-up period
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Number of side effects for new cases will be assessed at the 2nd week, the 1st month and 2nd month, and the 3rd month follow-up. For old cases the number of side effects will be assessed only at the baseline survey and the 3rd month follow-up
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Number of opportunistic infection within 3 months
Tidsramme: Number of opportunistic infection for new cases will be assessed at the 2nd week, the 1st month and 2nd month, and the 3rd month follow-up. For old cases number of that will be assessed only at the baseline and the 3rd month follow-up
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Number of opportunistic infection will be measured at different time points within 3 months follow-up period(study period)
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Number of opportunistic infection for new cases will be assessed at the 2nd week, the 1st month and 2nd month, and the 3rd month follow-up. For old cases number of that will be assessed only at the baseline and the 3rd month follow-up
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Mortality
Tidsramme: Mortality will be assessed the 3rd month follow-up
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Measurement of the number of change of mortality
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Mortality will be assessed the 3rd month follow-up
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Studieleder: Weibing Zheng, Bachelor, Baoshan CDC
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2011
Primær fullføring (Forventet)
1. september 2011
Studiet fullført (Forventet)
1. oktober 2011
Datoer for studieregistrering
Først innsendt
18. juni 2011
Først innsendt som oppfylte QC-kriteriene
15. juli 2011
Først lagt ut (Anslag)
18. juli 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
18. juli 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. juli 2011
Sist bekreftet
1. juli 2011
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- BSCDC2011HIV/AIDS
- BSWSJ2011HIV/AIDS (Annet stipend/finansieringsnummer: Grantor)
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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Kliniske studier på Phone call intervention, no phone call intervention
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