Needs Assessment Evaluating Quality of Life Issues for Gastroparesis Patients and Caregivers
17. maj 2013 opdateret af: University of Florida
The project will involve conducting a Needs Assessment for Gastroparesis patients and their caregivers with the goal of identifying quality of life issues associated with this disease.
Identifying these issues will ameliorate management and support systems for gastroparesis currently existent in the community and, hopefully, provide information for the establishment of more resources to assist the patients and their families.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
This project will involve: a) distributing questionnaires to up to 200 participants (100 patients and 100 caregivers) at the Shands Gastrointestinal clinic and b) focus groups including patients, medical provider, and the clinic case manager.
The questionnaires will provide information on the relative effect of gastroparesis on the quality of life of the patients and their caregivers.
Assessment of this needs assessment will then help identify areas of potential resource improvement and mobilization to provide support for the patients and their family members.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
68
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Florida
-
Gainesville, Florida, Forenede Stater, 32611
- University of Florida
-
-
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
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
The research plan involves reviewing patient records to identify potential subjects.
Questionnaires will be distributed to gastroparesis patients and their caregivers during their visit to the GI clinic at the day of enrollment and at six-month intervals for a two-year follow-up period, after informed consent has been obtained.
Patients and caregivers will also be recruited by telephone.
Gastroparesis patients, who have an established patient-physician relationship with Dr. Sultan, will be contacted by telephone in order to inquire about their interest in participating in the study.
The details of the study, including the questionnaires, risks, and potential benefits will be discussed over the phone.
Then, if patients and/or their caregivers are willing to participate in the study, the informed consent forms and the questionnaires will be mailed to them with a posted envelope to be returned to Dr. Sultan by mail.
Beskrivelse
Inclusion Criteria:
- Gastroparesis patients at the GI clinic of Shands Hospital at the University of Florida
- Caregivers to Gastroparesis patients at the GI clinic of Shands Hospital at the University of Florida
Exclusion Criteria:
- Inability to fill out the questionnaires by any cause
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Gastroparesis Patients
|
|
Gastroparesis Patients' Caregivers
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Score in a Quality of life assessment Questionnaire
Tidsramme: During the clinicial visit at the day of enrollment(Day 1)
|
During the clinicial visit at the day of enrollment(Day 1)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Score in a Quality of life assessment Questionnaire
Tidsramme: 1st follow-up, at 6 months from Date of enrollment
|
1st follow-up, at 6 months from Date of enrollment
|
|
Score in a Quality of life assessment Questionnaire
Tidsramme: 2nd follow-up, at 12 months from date of enrollment
|
2nd follow-up, at 12 months from date of enrollment
|
|
Score in a Quality of life assessment Questionnaire
Tidsramme: 3rd follow-up, at 18 months form date of enrollment
|
3rd follow-up, at 18 months form date of enrollment
|
|
Score in a Quality of life assessment Questionnaire
Tidsramme: 4th(last) follow-up, At 24 months form date of enrollment
|
4th(last) follow-up, At 24 months form date of enrollment
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Shahnaz Sultan, MD, University of Florida
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. januar 2010
Primær færdiggørelse (Faktiske)
1. februar 2013
Studieafslutning (Faktiske)
1. februar 2013
Datoer for studieregistrering
Først indsendt
24. marts 2011
Først indsendt, der opfyldte QC-kriterier
1. april 2011
Først opslået (Skøn)
5. april 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
20. maj 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. maj 2013
Sidst verificeret
1. maj 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 693-2009
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 .
Kliniske forsøg med Gastroparese
-
The Cleveland ClinicAktiv, ikke rekrutterendeGastroparesis-lignende symptomerForenede Stater