NCT04688359

Brief Summary

Previous Icelandic studies regarding prevalence of diabetes have mostly used data from the capital area. Information on the proportion of people at risk at developing T2DM or having undiagnosed T2DM among people living in rural Northern Iceland is unknown. Clinical guidelines recommend that patients with prediabetes (diabetes warning signs) should be referred to a counselling program. The study will evaluate effectiveness of nurse-coordinated Guided Self-Determination (GSD) follow up program toward health promotion, for people at risk of T2DM.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2020

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2023

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

December 1, 2020

Last Update Submit

May 23, 2023

Conditions

Pre-diabetesCardiovascular Risk FactorT2DM (Type 2 Diabetes Mellitus)Primary Health Care

Keywords

Pre-diabetesCardiovascular Risk FactorsGuided Self DeterminationInterventionPrimary Health Care

Outcome Measures

Primary Outcomes (2)

  • Cardiovascular Risk Factors changes up to one year after an intervention

    Changes for each participant from Baseline to endpoint on CVR factors, changes of risk measured in percentages (%) compared to normal risk in the Icelandic population from beginning to end of intervention. Using the Icelandic cardiovascular risk factor calculator.

    0- 6 months and 1 year

  • Measurements behind the Icelandic heart association risk calculator

    Changes from baseline to endpoint: * Weight and height (will be combined to report BMI in kg/m\^2) * Systolic blood pressure: In mm hg * Cholesterol: in mmol/L * HDL-Cholesterol: in mmol/L * Triglycerides measurements: in mmol/L, * Regular physical activity: yes/no * Smoking: never, stopped, 1/2 pack or less a day, 1/2 to 1 pack a day, 1 pack or more * Do you have diabetes: yes/no, * Do gender parents, brothers or sisters of same parents, have cardiovascular diseases : Yes/No

    0- 6 months and 1 year

Secondary Outcomes (6)

  • Changes in HbA1c level

    0- 6 months and 1 year

  • FINDRISC risk score "Diabetes Risk Score questionnaire"

    0- 6 months and 1 year

  • WHO-5 Quality of Life (QoL) questionnaire

    0- 6 months and 1 year

  • EQ-5D-5L Questionnaire of self rated health.

    0- 6 months and 1 year

  • Health Literacy (HL) questionnaire Icelandic version: HLS-EU-Q16IS.

    0- 6 months and 1 year

  • +1 more secondary outcomes

Other Outcomes (2)

  • Changes in fastening glucose from start point to endpoint in both groups

    0- 6 months and 1 year

  • LDL cholesterol changes from start point to endpoint in both groups

    0- 6 months and 1 year

Study Arms (2)

Intervention group

EXPERIMENTAL

Those receiving nurse-lead Guided Self Determination (GSD) for one to three times over six months starting four to six months after recruitment and first measurement.

Behavioral: Guided Self Determination

Control group

NO INTERVENTION

Those not receiving nurse-lead Guided Self Determination (GSD) for one to three times over six months starting four to six months after recruitment and first measurement.

Interventions

Guided Self DeterminationBEHAVIORAL

Nurse lead intervention in primary care

Also known as: GSD
Intervention group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI ≥ 30 kg/m2,
  • score ≥ 9 on FINDRISC,
  • HbA1c level ≥ 42 mmol/mol.
  • Non-blood-glucose-lowering medical treated T2DM.

You may not qualify if:

  • People diagnosed with Diabetes at strart-point.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Akureyri

Akureyri, 600, Iceland

Location

Related Publications (15)

  • Andersen K, Aspelund T, Gudmundsson EF, Siggeirsdottir K, Thorolfsdottir RB, Sigurdsson G, Gudnason V. [Five decades of coronary artery disease in Iceland. Data from the Icelandic Heart Association]. Laeknabladid. 2017 Oktober;103(10):411-420. doi: 10.17992/lbl.2017.10.153. Icelandic.

    PMID: 29044036BACKGROUND

  • Kong AP, Luk AO, Chan JC. Detecting people at high risk of type 2 diabetes- How do we find them and who should be treated? Best Pract Res Clin Endocrinol Metab. 2016 Jun;30(3):345-55. doi: 10.1016/j.beem.2016.06.003. Epub 2016 Jun 11.

    PMID: 27432070BACKGROUND

  • American Diabetes Association. Standards of Medical Care in Diabetes-2016 Abridged for Primary Care Providers. Clin Diabetes. 2016 Jan;34(1):3-21. doi: 10.2337/diaclin.34.1.3. No abstract available.

    PMID: 26807004BACKGROUND

  • Zoffmann V, Kirkevold M. Realizing empowerment in difficult diabetes care: a guided self-determination intervention. Qual Health Res. 2012 Jan;22(1):103-18. doi: 10.1177/1049732311420735. Epub 2011 Aug 29.

    PMID: 21876206BACKGROUND

  • IDF.org,( 2017). International Diabetes Federation,Webside. About Diabetes.accessed 28th of June 2018

    BACKGROUND

  • Bahler C, Huber CA, Brungger B, Reich O. Multimorbidity, health care utilization and costs in an elderly community-dwelling population: a claims data based observational study. BMC Health Serv Res. 2015 Jan 22;15:23. doi: 10.1186/s12913-015-0698-2.

    PMID: 25609174BACKGROUND

  • Thorsson B, Aspelund T, Harris TB, Launer LJ, Gudnason V. [Trends in body weight and diabetes in forty years in Iceland]. Laeknabladid. 2009 Apr;95(4):259-66. Icelandic.

    PMID: 19420407BACKGROUND

  • Zhang Y, Hu G, Zhang L, Mayo R, Chen L. A novel testing model for opportunistic screening of pre-diabetes and diabetes among U.S. adults. PLoS One. 2015 Mar 19;10(3):e0120382. doi: 10.1371/journal.pone.0120382. eCollection 2015.

    PMID: 25790106BACKGROUND

  • World Health Organization. (2018). Diabetes fact sheet. Available from: World Health Organization, web site: http: //www.who.int/mediacentre/factsheeds/fs312/en (accessed 28. June 2018)

    BACKGROUND

  • Saaristo T, Moilanen L, Jokelainen J, Korpi-Hyovalti E, Vanhala M, Saltevo J, Niskanen L, Peltonen M, Oksa H, Cederberg H, Tuomilehto J, Uusitupa M, Keinanen-Kiukaanniemi S. Cardiometabolic profile of people screened for high risk of type 2 diabetes in a national diabetes prevention programme (FIN-D2D). Prim Care Diabetes. 2010 Dec;4(4):231-9. doi: 10.1016/j.pcd.2010.05.005. Epub 2010 Jun 18.

    PMID: 21134669BACKGROUND

  • Steinarsson AO, Rawshani A, Gudbjornsdottir S, Franzen S, Svensson AM, Sattar N. Short-term progression of cardiometabolic risk factors in relation to age at type 2 diabetes diagnosis: a longitudinal observational study of 100,606 individuals from the Swedish National Diabetes Register. Diabetologia. 2018 Mar;61(3):599-606. doi: 10.1007/s00125-017-4532-8. Epub 2018 Jan 9.

    PMID: 29318343BACKGROUND

  • Laurant M, van der Biezen M, Wijers N, Watananirun K, Kontopantelis E, van Vught AJ. Nurses as substitutes for doctors in primary care. Cochrane Database Syst Rev. 2018 Jul 16;7(7):CD001271. doi: 10.1002/14651858.CD001271.pub3.

    PMID: 30011347BACKGROUND

  • Gustafsdottir SS, Sigurdardottir AK, Arnadottir SA, Heimisson GT, Martensson L. Translation and cross-cultural adaptation of the European Health Literacy Survey Questionnaire, HLS-EU-Q16: the Icelandic version. BMC Public Health. 2020 Jan 14;20(1):61. doi: 10.1186/s12889-020-8162-6.

    PMID: 31937293BACKGROUND

  • Seidu S, Walker NS, Bodicoat DH, Davies MJ, Khunti K. A systematic review of interventions targeting primary care or community based professionals on cardio-metabolic risk factor control in people with diabetes. Diabetes Res Clin Pract. 2016 Mar;113:1-13. doi: 10.1016/j.diabres.2016.01.022. Epub 2016 Jan 21.

    PMID: 26972954RESULT

  • Arnardottir E, Sigurdardottir AK, Skinner T, Graue M, Kolltveit BH. Prediabetes and cardiovascular risk factors: the effectiveness of a guided self-determination counselling approach in primary health care, a randomized controlled trial. BMC Public Health. 2024 Nov 1;24(1):3035. doi: 10.1186/s12889-024-20538-1.

    PMID: 39487428DERIVED

Related Links

MeSH Terms

Conditions

Glucose IntoleranceDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Study Officials

  • Arun K Sigurdardottir, PhD

    University of Akureyri

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participants is informed of two groups but not which group he is allocated in.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 2 groups one intervention group and one control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2020

First Posted

December 30, 2020

Study Start

November 1, 2021

Primary Completion

January 19, 2023

Study Completion

January 19, 2023

Last Updated

May 24, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

IC(1)