Ready to Act - Health Education in People With Hyperglycaemia

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01945645
• Other study ID #: Ready to Act
• Secondary ID: 20000183
• Status: Completed
• Phase: N/A
• First received: September 14, 2013
• Last updated: September 14, 2013
• Start date: September 2006
• Est. completion date: December 2010

Study information

• Verified date: September 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 509
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 69 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Behavior
• Diabetes Mellitus, Type 2
• Hyperglycemia
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Ready to act
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.

Locations

Country	Name	City	State
Denmark	Department of Public health	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	se-cholesterol	Serum cholesterol is the total amount of cholesterol found in the blood.	3 years after intervention, dec 2010	No
Secondary	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)	No
Secondary	Blood pressure	Systolic and diastolic blood pressure were measured	3 years after intervention, dec 2010	No
Secondary	Physical activity	Physical activity was measured using the International Physical Activity questionnaire (IPAQ-short form)	3 years after intervention, dec 2010	No
Secondary	Smoking	Smoking status was assessed by standard questions.	3 years after intervention, 2010	No