Pre-diabetesNCT04688359
Effectiveness of Nurse-coordinated Follow-up Program in Primary Care for People at Risk for T2DM
A study testing Guided Self Determination in people with Pre-diabetes and Cardiovascular Risk Factor, run by University of Akureyri at 1 site in Iceland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-diabetes, Cardiovascular Risk Factor, T2DM (Type 2 Diabetes Mellitus)
- What is being tested?
- Guided Self Determination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteIceland
- Study dates
- 1 Nov 2021to 19 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥ 30 kg/m2,
- score ≥ 9 on FINDRISC,
- HbA1c level ≥ 42 mmol/mol.
- Non-blood-glucose-lowering medical treated T2DM.
Who cannot join
- People diagnosed with Diabetes at strart-point.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nurse-coordinated Follow-up Program in Primary Care: a Mixed-method Complex Intervention Feasibility and RCT Pilot Trial Among People at Risk for T2DM.
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.
Read the detailed description
Prevalence of type 2 Diabetes Mellitus (T2DM) a major health problem is rising. This metabolic disease characterized by the inability to effectively metabolize glucose, and often also a silent and sneaky onset. A lag is often found between diagnose and onset of the disease. Diabetes related complications are expensive for the society, and reduce quality of life for the individual.
Around one out of three with T2DM in an Icelandic study were unaware of their T2DM when fasting blood glucose was measured. In the U.S.A., the average interval between onset of the disease and diagnose is seven years, and the authors claimed that 30% of people with T2DM are undiagnosed, with increased risk for chronic diabetes complications higher Cardiovascular risk factors (CVR), and higher premature death for people with early onset of T2DM compared to late onset of T2DM.
Research have shown 1.83-fold higher risk of CVD for those with prediabetes and 2.26-fold higher risk for individuals with undiagnosed diabetes compared to individuals with normal HbA1c. These results highlight the pivotal need to prevent development of diabetes, as there is an association between increased obesity and increased prevalence of T2DM as Type 2 diabetes (T2DM) is also found to be a major risk factor for cardiovascular diseases.
Icelandic people and especially men are becoming more overweight. From the years 1968-2012, body mass index (BMI) increased by 11%, from 25.8 kg/m2 to 28.7 kg/m2 for men between 50-69 years. In women 50-69 years, the BMI increased from 25.2 kg/m2 to 27.2 kg/m2, or 8%. These results highlight the pivotal need to prevent development of diabetes in Iceland, as there is an association between increased obesity and increased prevalence of type 2 Diabetes Mellitus (T2DM).
A Guided Self-Determination (GSD) is based on a strong theoretical value and is a well establish nurse-led interventional method for people diagnosed with T2DM and other diseases. To our knowledge this is the first time that GSD is used in Iceland. Nurses working in primary care, at The Health Care Institution of North Iceland (HSN), in Akureyri, Husavik and Sauðarkrokur, will offer the GSD intervention. Before the intervention the nurses will receive teaching and consultation from an experienced GSD diabetic nurse. During their use of the GSD method they will have counseling from the experienced GSD nurse and the PhD student. A systematic review claimed, that multi-professional interventions are more effective in improving diabetes care compared to single professional interventions.
A recent Cochrane review using data from 18 trials, investigated the impact of nurses working as substitutes for primary care doctors. The results demonstrate that using the capacity and skills of nurses to deliver primary healthcare services leads to similar or better patient health and higher patient satisfaction. As such, this might be an important strategy to improve access, efficiency, and quality of care, and at the same time strengthen health promotion aspects of care and management of chronic diseases and increase teamwork in primary care.
This study is a part of doctoral student study. This PhD project is collaboration between University of Akureyri, Iceland (UNAK), Western Norway University of Applied Sciences (HVL) and the Health Care Institution of North Iceland (HSN). HVL has a considerably experience in researching diabetes through the Diabetes Research Group for BEST Practice (DiaBEST). The research group DiaBEST consist of researchers from Bergen University Collage, the University of Bergen and the University of Stavanger. The projects contribute to increase knowledge about and implementation of evidence-based practice within primary care.
- Conditions
- Pre-diabetes, Cardiovascular Risk Factor, T2DM (Type 2 Diabetes Mellitus), Primary Health Care
- Being tested
- Guided Self Determination
- Keywords
- Pre-diabetes, Cardiovascular Risk Factors, Guided Self Determination, Intervention, Primary Health Care
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Self DeterminationBehavioural
Also called GSD
Nurse lead intervention in primary care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 0- 6 months and 1 year
Secondary outcomes (6)
Changes in HbA1c level
Changes in HbA1c mmol/L, (normal less than 42 mmol/mol, prediabetes 42-48 mmol/mol, diabetes over 48 mmol/mol)
Measured: 0- 6 months and 1 year
FINDRISC risk score "Diabetes Risk Score questionnaire"
Changes from beginning to end of intervention between groups score reported on a scale from 0 - 26, (normal under 9, increased risk 9 and over)
Measured: 0- 6 months and 1 year
WHO-5 Quality of Life (QoL) questionnaire
Changes within and between groups from baseline to endpoint. Well-being index. The WHO-5 consists of five statements, which respondents rate according to the scale below (in relation to the past two weeks).
marking x on 5 = All of the time marking x on 4 = Most of the time marking x on 3 = More than half of the time marking x on 2 = Less than half of the time marking x on 1 = Some of the time marking x on 0 = At no time The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
Measured: 0- 6 months and 1 year
EQ-5D-5L Questionnaire of self rated health.
Changes from beginning to end of intervention within and between groups scoring from one to five at each of the five dimension 3125 definition of health state, Higher score worse outcome: Mobility dimension; Self-care dimension; Usual activities dimension; Pain/discomfort dimension; Anxiety/depression dimension.
Respondents self-rate their level of severity for each dimension using five-levels:
1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems 5 = unable to do/having extreme problems.
Visual analogue scale; mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. At the both ends of the scale that the bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) "the best health you can imagine". higher score better outcome
Measured: 0- 6 months and 1 year
Health Literacy (HL) questionnaire Icelandic version: HLS-EU-Q16IS.
Changes from beginning to end of intervention within and between groups 16 questions regarding health literacy. The Icelandic version asking the person from on the scale from; "very difficult", "fairly difficult", "fairly easy", "very easy",
fairly easy and very easy are united into "easy" (scored with 1) very difficult, fairly difficult are united into "difficult" (scored with 0). score can range from 0 (low/no Health Literacy) to 16 (high Health Literacy)
(Results will be grouped into two groups: less than 13 and over 13 points according to prior research results in Iceland)
Measured: 0- 6 months and 1 year
Hip-to-Waist ratio
Changes from beginning to end of intervention in both groups Hip-to-Waist ratio measurement: cm/cm, increased risk if ratio over 1.0
Measured: 0- 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Nov 2021
- Primary completion19 Jan 2023
- Study completion19 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups one intervention group and one control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Akureyri
- Sponsor type
- University, hospital or other
- Collaborators
- Western Norway University of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Arun K Sigurdardottir, PhD, Study director, University of Akureyri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688359
- Sponsor's protocol ID
- UAkureyri
- Status last verified
- May 2023
- First submitted
- 1 Dec 2020
- Last updated
- 24 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29044036Kong 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.
PubMed 27432070American 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.
PubMed 26807004Zoffmann 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.
PubMed 21876206IDF.org,( 2017). International Diabetes Federation,Webside. About Diabetes.accessed 28th of June 2018
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.
PubMed 25609174Thorsson 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.
PubMed 19420407Zhang 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.
PubMed 25790106World 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)
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.
PubMed 21134669Steinarsson 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.
PubMed 29318343Laurant 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.
PubMed 30011347Gustafsdottir 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.
PubMed 31937293Seidu 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.
PubMed 26972954Arnardottir 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.
PubMed 39487428
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-coordinated Follow-up Program in Primary Care: a Mixed-method Complex Intervention Feasibility and RCT Pilot Trial Among People at Risk for T2DM.
- ClinicalTrials.gov ID
- NCT04688359
- Acronym / sponsor ID
- UAkureyri
- Conditions
- Pre-diabetes, Cardiovascular Risk Factor, T2DM (Type 2 Diabetes Mellitus), Primary Health Care
- Keywords
- Pre-diabetes, Cardiovascular Risk Factors, Guided Self Determination, Intervention, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of AkureyriUniversity, hospital or other
- Collaborators
- Western Norway University of Applied Sciences
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 19 Jan 2023 (actual)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prevalence of type 2 Diabetes Mellitus (T2DM) a major health problem is rising. This metabolic disease characterized by the inability to effectively metabolize glucose, and often also a silent and sneaky onset. A lag is often found between diagnose and onset of the disease. Diabetes related complications are expensive for the society, and reduce quality of life for the individual.
Around one out of three with T2DM in an Icelandic study were unaware of their T2DM when fasting blood glucose was measured. In the U.S.A., the average interval between onset of the disease and diagnose is seven years, and the authors claimed that 30% of people with T2DM are undiagnosed, with increased risk for chronic diabetes complications higher Cardiovascular risk factors (CVR), and higher premature death for people with early onset of T2DM compared to late onset of T2DM.
Research have shown 1.83-fold higher risk of CVD for those with prediabetes and 2.26-fold higher risk for individuals with undiagnosed diabetes compared to individuals with normal HbA1c. These results highlight the pivotal need to prevent development of diabetes, as there is an association between increased obesity and increased prevalence of T2DM as Type 2 diabetes (T2DM) is also found to be a major risk factor for cardiovascular diseases.
Icelandic people and especially men are becoming more overweight. From the years 1968-2012, body mass index (BMI) increased by 11%, from 25.8 kg/m2 to 28.7 kg/m2 for men between 50-69 years. In women 50-69 years, the BMI increased from 25.2 kg/m2 to 27.2 kg/m2, or 8%. These results highlight the pivotal need to prevent development of diabetes in Iceland, as there is an association between increased obesity and increased prevalence of type 2 Diabetes Mellitus (T2DM).
A Guided Self-Determination (GSD) is based on a strong theoretical value and is a well establish nurse-led interventional method for people diagnosed with T2DM and other diseases. To our knowledge this is the first time that GSD is used in Iceland. Nurses working in primary care, at The Health Care Institution of North Iceland (HSN), in Akureyri, Husavik and Sauðarkrokur, will offer the GSD intervention. Before the intervention the nurses will receive teaching and consultation from an experienced GSD diabetic nurse. During their use of the GSD method they will have counseling from the experienced GSD nurse and the PhD student. A systematic review claimed, that multi-professional interventions are more effective in improving diabetes care compared to single professional interventions.
A recent Cochrane review using data from 18 trials, investigated the impact of nurses working as substitutes for primary care doctors. The results demonstrate that using the capacity and skills of nurses to deliver primary healthcare services leads to similar or better patient health and higher patient satisfaction. As such, this might be an important strategy to improve access, efficiency, and quality of care, and at the same time strengthen health promotion aspects of care and management of chronic diseases and increase teamwork in primary care.
This study is a part of doctoral student study. This PhD project is collaboration between University of Akureyri, Iceland (UNAK), Western Norway University of Applied Sciences (HVL) and the Health Care Institution of North Iceland (HSN). HVL has a considerably experience in researching diabetes through the Diabetes Research Group for BEST Practice (DiaBEST). The research group DiaBEST consist of researchers from Bergen University Collage, the University of Bergen and the University of Stavanger. The projects contribute to increase knowledge about and implementation of evidence-based practice within primary care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 groups one intervention group and one control group
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Guided Self DeterminationThose 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. |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI ≥ 30 kg/m2,
- score ≥ 9 on FINDRISC,
- HbA1c level ≥ 42 mmol/mol.
- Non-blood-glucose-lowering medical treated T2DM.
Key exclusion criteria (1 listed)
- People diagnosed with Diabetes at strart-point.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Self DeterminationAlso: GSDNurse lead intervention in primary care | Behavioural | Intervention group |
Primary outcome
Cardiovascular Risk Factors changes up to one year after an intervention
Time frame: 0- 6 months and 1 year
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.
Measurements behind the Icelandic heart association risk calculator
Time frame: 0- 6 months and 1 year
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
6 secondary outcomes
Changes in HbA1c level
Time frame: 0- 6 months and 1 year
FINDRISC risk score "Diabetes Risk Score questionnaire"
Time frame: 0- 6 months and 1 year
WHO-5 Quality of Life (QoL) questionnaire
Time frame: 0- 6 months and 1 year
EQ-5D-5L Questionnaire of self rated health.
Time frame: 0- 6 months and 1 year
Health Literacy (HL) questionnaire Icelandic version: HLS-EU-Q16IS.
Time frame: 0- 6 months and 1 year
Hip-to-Waist ratio
Time frame: 0- 6 months and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Background: PubMed 29044036Andersen 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.
- Background: PubMed 27432070Kong 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.
- Background: PubMed 26807004American 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.
- Background: PubMed 21876206Zoffmann 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.
- BackgroundIDF.org,( 2017). International Diabetes Federation,Webside. About Diabetes.accessed 28th of June 2018
- Background: PubMed 25609174Bahler 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.
- Background: PubMed 19420407Thorsson 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.
- Background: PubMed 25790106Zhang 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.
- BackgroundWorld 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: PubMed 21134669Saaristo 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.
- Background: PubMed 29318343Steinarsson 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.
- Background: PubMed 30011347Laurant 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.
- Diabetes fact sheet 2018Link provided by the sponsor.
- International Diabetes Federation websideLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arun K Sigurdardottir, PhD study director
University of Akureyri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Self Determination in people with Pre-diabetes and Cardiovascular Risk Factor, run by University of Akureyri at 1 site in Iceland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Risk Factors changes up to one year after an intervention (time frame: 0- 6 months and 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04688359, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.