Clinical trial NCT04688359: Effectiveness of Nurse-coordinated Follow-up Program in Primary Care for People at Risk for T2DM
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Akureyri
Sponsor class: OTHER
Collaborators: name: Western Norway University of Applied Sciences
First posted: 2020-12-30
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups one intervention group and one control group
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria two of three:

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

Exclusion Criteria:

* People diagnosed with Diabetes at strart-point.

Primary outcomes:
measure: Cardiovascular Risk Factors changes up to one year after an intervention
timeFrame: 0- 6 months and 1 year
measure: Measurements behind the Icelandic heart association risk calculator
timeFrame: 0- 6 months and 1 year
Secondary outcomes:
measure: Changes in HbA1c level
timeFrame: 0- 6 months and 1 year
measure: FINDRISC risk score "Diabetes Risk Score questionnaire"
timeFrame: 0- 6 months and 1 year
measure: WHO-5 Quality of Life (QoL) questionnaire
timeFrame: 0- 6 months and 1 year
measure: EQ-5D-5L Questionnaire of self rated health.
timeFrame: 0- 6 months and 1 year
measure: Health Literacy (HL) questionnaire Icelandic version: HLS-EU-Q16IS.
timeFrame: 0- 6 months and 1 year
measure: Hip-to-Waist ratio
timeFrame: 0- 6 months and 1 year
Other outcomes:
measure: Changes in fastening glucose from start point to endpoint in both groups
timeFrame: 0- 6 months and 1 year
measure: LDL cholesterol changes from start point to endpoint in both groups
timeFrame: 0- 6 months and 1 year
Locations:
city: Akureyri
country: Iceland
facility: University of Akureyri
Study officials:
affiliation: University of Akureyri
name: Arun K Sigurdardottir, PhD
role: STUDY_DIRECTOR
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