Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Creative Writing for Type 2 Diabetes Management (CrewD)

18. september 2018 oppdatert av: Associacao Protectora dos Diabeticos de Portugal

Close Reading and Creative Writing - CrewD Program. An Alternative Educational Method for Group Care Intervention in Type 2 Diabetes Management. A Randomized Trial

This study is related to the development of a new model of Group Care for patients with Diabetes - the CrewD Program, incorporating close reading and creative writing in group education. A randomized trial was designed to evaluate this intervention.

Studieoversikt

Detaljert beskrivelse

A structured educational model for type 2 diabetic patients using Group Care is currently being used in several institutions for help managing diabetes in these patients. In this study, this model was adjusted by introducing literary texts and using narrative skills. A randomized trial was designed to determine whether group dynamic strategies using narrative and reading produce the same positive outcomes as a conventional group approach. A total of 49 patients with type 2 Diabetes were randomized to two different Group Care dynamics, one "control group", with a classical structured educational approach and another, "intervention group", with close reading and creative writing. Evaluation included anthropometrical measures, A1c and questionnaires for psychological evaluation.

Studietype

Intervensjonell

Registrering (Faktiske)

49

Fase

  • Ikke aktuelt

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 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Only patients with type 2 diabetes of >1 year known duration, aged < 85 years were included in the intervention.

Exclusion Criteria:

  • Patients that did not complete the four assessments.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: CrewD Program approach

The aim was to increase education about the disease by using narrative skills through the CrewD Program. The sessions were conducted by two group leaders: a health professional and a literature professor manager of creative writing groups.

Each session had a title, which parallels the classical structured educational approach (active comparator condition), which was known in advance by the subjects: a) Who I am in Diabetes?; b) Nutrition; c) The body where I live; d) Fears; e) Can attention change things?; and f) Roots.

Team leaders directed a discussion of different texts used in the sessions with the participants focusing on their feelings and on how the texts relate to themselves and to their diabetes. Patients were encouraged to participate and freely express their opinion.

The CrewD Program - Creative reading and writing in Diabetes Program - is a Diabetes self-management education and support program to help people with Diabetes coping with the disease.
Aktiv komparator: Classical structured education

Each session was 90 minutes long, with a similar internal structure in all of them. Each session included the following topics: a) Chronic Disease; b) Nutrition; c) Exercise; d) Complications; e) Self-management; and f) Diabetic foot. The sessions were held in a large room, in which the seats were arranged in circle. Every session was chaired by two healthcare providers, who worked as group leaders.

There was a different visual presentation in each session, with relevant theoretical information. A board with sheets of paper was available for use in the discussion along with brochures about the disease.

Patients were encouraged to actively participate and take part in group-problem solving. Group leaders guided the discussion by asking questions and encouraging the discussion.

The Classical educational approach consists in an educational method based on the presentation of relevant theoretical information to help people with Diabetes coping with the disease.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline in hemoglobin A1c levels at 6 months
Tidsramme: Up to 6 months
Hemoglobin A1c is measured in mmol/mol units.
Up to 6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline in weight at 6 months
Tidsramme: Up to 6 months
Weight is measured in Kg.
Up to 6 months
Change from baseline in fat mass at 6 months
Tidsramme: Up to 6 months
Fat mass is measured in Kg/m2
Up to 6 months
Change from baseline in waist circumference at 6 months
Tidsramme: Up to 6 months
Waist circumference is measured in cm
Up to 6 months
Change from baseline in self-reported quality of life at 6 months
Tidsramme: Up to 6 months
The Diabetes Quality of Life Questionnaire (DQOL) is a self-report scale to assess quality of life. This scale comprises 13 items that are grouped in 4 subscales: 1) satisfaction with treatment, 2) impact of treatment, 3) worry about the future effects of diabetes, and 4) worry about social/vocational issues. A total score may be also computed from the sum of the 13 items. Higher scores indicate poorer quality of life, ranging from 13 to 65.
Up to 6 months
Change from baseline in self-reported locus of control at 6 months
Tidsramme: Up to 6 months
Locus of control is measured using the Diabetes Specific Locus of Control Scale (DLOC), which is a self-report scale directed to diabetes patients. This scale comprises 13 items that are grouped in 3 subscales: 1) internal locus of control; 2) external locus of control; and 3) powerful other locus of control. Higher scores reflect higher locus of control in each of these dimensions.
Up to 6 months
Change from baseline in self-reported empathy at 6 months
Tidsramme: Up to 6 months
Empathy is measured using a questionnaire - Jefferson Scale of Physician Empathy (JSPE-R), which comprises 9 items. Self-reported empathy levels are measured through a total score that is derived from the sum of the 9 items. The total score range from 9 to 63, in which higher scores depict higher empathy levels.
Up to 6 months
Change from baseline in self-reported group satisfaction at 6 months
Tidsramme: Up to 6 months
Group satisfaction is measured using a questionnaire - Group Satisfaction Scale (GSS). The GSS assess 2 dimensions: 1) satisfaction with therapist subscale and 2) content/group process subscale. A total score may be also computed from the sum of the 12 items that comprise this scale. The scores range from 12 to 60, in which higher scores reflect higher satisfaction levels.
Up to 6 months
Change from baseline in self-reported health
Tidsramme: Up to 6 months
The 36-Item Short Form Survey is used to assess health perception. This scale comprises 36 items that are divided in 8 dimensions: 1) vitality; 2) physical functioning; 3) bodily pain; 4) general health perceptions; 5) physical role functioning; 6) emotional role functioning; 7) social role functioning; and 8) mental health. These subscales are transformed into a scale range from 0-100, in which lower scores indicate worse health perception.
Up to 6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studiestol: João Raposo, M.D., Associacao Protectora dos Diabeticos de Portugal

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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 (Faktiske)

5. januar 2017

Primær fullføring (Faktiske)

30. september 2017

Studiet fullført (Faktiske)

30. september 2017

Datoer for studieregistrering

Først innsendt

10. september 2018

Først innsendt som oppfylte QC-kriteriene

18. september 2018

Først lagt ut (Faktiske)

20. september 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. september 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. september 2018

Sist bekreftet

1. september 2018

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på CrewD Program

3
Abonnere