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Completed

NCT Number: NCT01945645

Ready to Act - Health Education in People With Hyperglycaemia

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Public health

Aarhus, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ready to act

Behavioral

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.

Primary outcomes

  1. Modelled cardiovascular disease risk

    Time frame: 3 years after intervention, dec 2010

    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

Secondary outcomes

  1. Glycated hemoglobin

    Time frame: 3 years after intervention, dec 2010

    Glycated hemoglobin (HbA1c)is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time

  2. se-cholesterol

    Time frame: 3 years after intervention, dec 2010

    Serum cholesterol is the total amount of cholesterol found in the blood.

  3. Patient Activation

    Time frame: One year and three year (2006, 2007, 2010)

    The Patient Activation Measure (PAM-13) is a composite measure of perceived skills, self-efficacy and knowledge.

  4. Blood pressure

    Time frame: 3 years after intervention, dec 2010

    Systolic and diastolic blood pressure were measured

  5. Physical activity

    Time frame: 3 years after intervention, dec 2010

    Physical activity was measured using the International Physical Activity questionnaire (IPAQ-short form)

  6. Smoking

    Time frame: 3 years after intervention, 2010

    Smoking status was assessed by standard questions.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Sep 18, 2013
Registry last updated
Sep 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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