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Ready to Act - Health Education in People With Hyperglycaemia

Primary Purpose

Type 2 Diabetes Mellitus, Behavior

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Ready to act
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes Mellitus focused on measuring Prevention, Screening, Type 2 diabetes, Action Competence, Family practice, Health Services Research

Eligibility Criteria

40 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Public health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
se-cholesterol
Serum cholesterol is the total amount of cholesterol found in the blood.
Patient Activation
The Patient Activation Measure (PAM-13) is a composite measure of perceived skills, self-efficacy and knowledge.
Blood pressure
Systolic and diastolic blood pressure were measured
Physical activity
Physical activity was measured using the International Physical Activity questionnaire (IPAQ-short form)
Smoking
Smoking status was assessed by standard questions.

Full Information

First Posted
September 14, 2013
Last Updated
September 14, 2013
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT01945645
Brief Title
Ready to Act - Health Education in People With Hyperglycaemia
Official Title
Ready to Act. A Health Education Programme for People With Screen-detected Hyperglycaemia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Behavior
Keywords
Prevention, Screening, Type 2 diabetes, Action Competence, Family practice, Health Services Research

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
509 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helle Terkildsen Maindal, MPH, PhD
Organizational Affiliation
Aarhus university, Department of Public health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Public health
City
Aarhus
Country
Denmark

12. IPD Sharing Statement

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Ready to Act - Health Education in People With Hyperglycaemia

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