Ready to Act - Health Education in People With Hyperglycaemia

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Behavior
• Intervention / Treatment: Behavioral: Ready to act

• Study Type: Interventional
• Enrollment (Actual): 509
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Department of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Helle Terkildsen Maindal, MPH, PhD, Aarhus University, Department of Public Health

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: September 14, 2013
• First Submitted That Met QC Criteria: September 14, 2013
• First Posted (Estimate): September 18, 2013

Study Record Updates

• Last Update Posted (Estimate): September 18, 2013
• Last Update Submitted That Met QC Criteria: September 14, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Type 2 diabetes; Screening; Prevention; Health Services Research; Family practice; Action Competence
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Ready to Act; 20000183 (Ethical approval)