Improving Diabetes Outcomes: a Couples Intervention
15. juni 2009 opdateret af: State University of New York - Upstate Medical University
Research has shown that diabetes affects both the patient and family, and that support from family and partners helps diabetes patients manage their illness better.
However, diabetes programs rarely involve the partner.
This is a study to develop and test an intervention that helps partners and patients who have type 2 diabetes better support each other.
The intervention will be delivered over the telephone to reach more people.
Our hypothesis is that an intervention that targets the couple has a greater effect on health and well-being of patients than one that targets the individual patient alone.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Research has shown that diabetes affects both the patient and family, and that support from family and partners helps diabetes patients manage their illness better.
However, diabetes programs rarely involve the partner.
This is a pilot proposal to develop and test an intervention that aims to both enlist the support of partners of diabetes patients, and enhance and improve the quality of that support.
We believe that the intervention will help the relationship and also will have a positive impact on medical (e.g.,blood sugar control), behavioral (e.g., increased exercise, better diet) and emotional (e.g., depression) outcomes.
The intervention will be implemented by telephone, in order to enhance the project's ability to reach a broader sample of patients.Forty-five couples will be recruited in which one partner has type 2 diabetes.
After initial testing and basic diabetes education, they will be assigned to one of three comparison groups.
For those in the intervention groups they will participate in 11 telephone contacts with a diabetes educator and a counselor and will receive education about diabetes, behavior change, emotional issues/couples communication, and problem solving techniques.
A manual will include readings, structured homework assignments, and self-monitoring logs.
They will be re-tested 2 weeks and 3 months after the intervention.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
45
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New York
-
Syracuse, New York, Forenede Stater, 13210
- State University of New York Upstate Medical University
-
-
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 95 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- greater than 21 years of age.
- diagnosed with type 2 diabetes for at least 1 year.
- have no severe complications (on dialysis, blindness, amputations, history of stroke)
- able to speak, read and hear English.
- married or cohabiting for > 1 year.
- have a telephone.
Exclusion Criteria:
- have a diagnosed psychiatric disorder.
- refuse audiotaping or other study procedures.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 1
Telephone support and behavior change for couples
|
Diabetes self-management education provided over the telephone either for individuals or couples
|
|
Aktiv komparator: 2
Telephone support and behavior change for individuals
|
Diabetes self-management education provided over the telephone either for individuals or couples
|
|
Placebo komparator: 3
Limited diabetes self-management education
|
Begrænset undervisning i selvstyring af diabetes, der tilbydes over telefonen, tjener som en forbedret sædvanlig behandlingskontrolintervention
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
blood glucose control (hemoglobin A1c)
Tidsramme: 2 and 14 weeks post
|
2 and 14 weeks post
|
|
blood pressure
Tidsramme: 2 and 14 weeks post
|
2 and 14 weeks post
|
|
diabetes regimen adherence
Tidsramme: at 2 and 14 weeks post
|
at 2 and 14 weeks post
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
lipids
Tidsramme: at 2 and 14 weeks post intervention
|
at 2 and 14 weeks post intervention
|
|
weight/BMI
Tidsramme: at 2 and 14 weeks post intervention
|
at 2 and 14 weeks post intervention
|
|
food habits
Tidsramme: at 2 and 14 weeks post intervention
|
at 2 and 14 weeks post intervention
|
|
activity habits
Tidsramme: at 2 and 14 weeks post intervention
|
at 2 and 14 weeks post intervention
|
|
health-related quality of life
Tidsramme: at 2 and 14 weeks post
|
at 2 and 14 weeks post
|
|
relationship quality
Tidsramme: at 2 and 14 weeks post intervention
|
at 2 and 14 weeks post intervention
|
|
diabetes self-efficacy
Tidsramme: at 2 and 14 weeks post intervention
|
at 2 and 14 weeks post intervention
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Paula M Trief, PhD, State University of New York - Upstate Medical University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Kiecolt-Glaser JK, Newton TL. Marriage and health: his and hers. Psychol Bull. 2001 Jul;127(4):472-503. doi: 10.1037/0033-2909.127.4.472.
- Fisher L, Chesla CA, Bartz RJ, Gilliss C, Skaff MA, Sabogal F, Kanter RA, Lutz CP. The family and type 2 diabetes: a framework for intervention. Diabetes Educ. 1998 Sep-Oct;24(5):599-607. doi: 10.1177/014572179802400504.
- Trief PM, Ploutz-Snyder R, Britton KD, Weinstock RS. The relationship between marital quality and adherence to the diabetes care regimen. Ann Behav Med. 2004 Jun;27(3):148-54. doi: 10.1207/s15324796abm2703_2.
- Trief PM, Himes CL, Orendorff R, Weinstock RS. The marital relationship and psychosocial adaptation and glycemic control of individuals with diabetes. Diabetes Care. 2001 Aug;24(8):1384-9. doi: 10.2337/diacare.24.8.1384.
- Trief PM, Wade MJ, Britton KD, Weinstock RS. A prospective analysis of marital relationship factors and quality of life in diabetes. Diabetes Care. 2002 Jul;25(7):1154-8. doi: 10.2337/diacare.25.7.1154.
- Garfield SA, Malozowski S, Chin MH, Narayan KM, Glasgow RE, Green LW, Hiss RG, Krumholz HM; Diabetes Mellitus Interagency Coordinating Committee (DIMCC) Translation Conference Working Group. Considerations for diabetes translational research in real-world settings. Diabetes Care. 2003 Sep;26(9):2670-4. doi: 10.2337/diacare.26.9.2670. No abstract available.
- Delamater AM, Jacobson AM, Anderson B, Cox D, Fisher L, Lustman P, Rubin R, Wysocki T; Psychosocial Therapies Working Group. Psychosocial therapies in diabetes: report of the Psychosocial Therapies Working Group. Diabetes Care. 2001 Jul;24(7):1286-92. doi: 10.2337/diacare.24.7.1286.
- Trief P, Sandberg JG, Ploutz-Snyder R, Brittain R, Cibula D, Scales K, Weinstock RS. Promoting couples collaboration in type 2 diabetes: the diabetes support project pilot data. Fam Syst Health. 2011 Sep;29(3):253-61. doi: 10.1037/a0024564.
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 2006
Primær færdiggørelse (Faktiske)
1. februar 2009
Studieafslutning (Faktiske)
1. februar 2009
Datoer for studieregistrering
Først indsendt
7. november 2005
Først indsendt, der opfyldte QC-kriterier
7. november 2005
Først opslået (Skøn)
8. november 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
16. juni 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. juni 2009
Sidst verificeret
1. juni 2009
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1R34DK06799501A2
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