Ready to Act - Health Education in People With Hyperglycaemia

Study Overview
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Brief Summary
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A pre-randomized study in primary health care was designed to investigate health education in a subpopulation extracted from general practitioners (GPs) in one Danish county in the treatment arm of the ADDITION (Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care) study, DK. The overall objective of the 'Ready to Act' health education programme was to support the participants' competences in daily life and act appropriately with respect to their dysglycaemic condition. The achievement of action competence involved four learning objectives: intrinsic motivation, informed decision-making, action experience and social involvement. The programme was delivered in primary care settings (health centre or GP surgeries) by nurses, dieticians, physiotherapists and GPs.

Official Title
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Ready to Act. A Health Education Programme for People With Screen-detected Hyperglycaemia

Conditions
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Type 2 Diabetes Mellitus, Behavior

Intervention / Treatment
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* Behavioral: Ready to act


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 40-69 years at the time of screening and diagnosed with screen-detected T2D, IGT or IFG (according to WHO criteria). Exclusion Criteria: women who were pregnant or lactating, those with a psychotic illness or an illness with a prognosis of less than one year.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The Ready to Act programme aimed to promote health-related action competence including motivation, informed decision-making, action experience and social involvement The intervention was delivered across a number of primary care settings including the GP office, health centre and pharmacy. The programme consisted of two individual counselling interviews and eight group sessions, which totalled 18 hours within a three month period. | Behavioral: Ready to act<br>* The Ready to Act programme aimed to promote health-related action competence including motivation, informed decision-making, action experience and social involvement The intervention was delivered across a number of primary care settings including the GP office, health centre and pharmacy. The programme consisted of two individual counselling interviews and eight group sessions, which totalled 18 hours within a three month period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modelled cardiovascular disease risk | The risk is measured by a SCORE model uses information on age, sex, smoking status, total cholesterol and systolic blood pressure. It provides an estimate of ten-year fatal cardiovascular disease risk | 3 years after intervention, dec 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated hemoglobin | Glycated hemoglobin (HbA1c)is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time | 3 years after intervention, dec 2010 | 
| se-cholesterol | Serum cholesterol is the total amount of cholesterol found in the blood. | 3 years after intervention, dec 2010 | 
| Patient Activation | The Patient Activation Measure (PAM-13) is a composite measure of perceived skills, self-efficacy and knowledge. | One year and three year (2006, 2007, 2010) | 
| Blood pressure | Systolic and diastolic blood pressure were measured | 3 years after intervention, dec 2010 | 
| Physical activity | Physical activity was measured using the International Physical Activity questionnaire (IPAQ-short form) | 3 years after intervention, dec 2010 | 
| Smoking | Smoking status was assessed by standard questions. | 3 years after intervention, 2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Screening, Type 2 diabetes, Action Competence, Family practice, Health Services Research