NCT01945645

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
509

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2013

Completed
Last Updated

September 18, 2013

Status Verified

September 1, 2013

Enrollment Period

4.3 years

First QC Date

September 14, 2013

Last Update Submit

September 14, 2013

Conditions

Type 2 Diabetes MellitusBehavior

Keywords

PreventionScreeningType 2 diabetesAction CompetenceFamily practiceHealth Services Research

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Glycated hemoglobin

    3 years after intervention, dec 2010

  • se-cholesterol

    3 years after intervention, dec 2010

  • Patient Activation

    One year and three year (2006, 2007, 2010)

  • Blood pressure

    3 years after intervention, dec 2010

  • Physical activity

    3 years after intervention, dec 2010

  • +1 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

Ready to actBEHAVIORAL

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

Eligibility Criteria

Age40 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 40-69 years at the time of screening and diagnosed with screen-detected T2D, IGT or IFG (according to WHO criteria).

You may not qualify if:

  • women who were pregnant or lactating, those with a psychotic illness or an illness with a prognosis of less than one year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Public health

Aarhus, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Behavior

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Helle Terkildsen Maindal, MPH, PhD

    Aarhus university, Department of Public health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2013

First Posted

September 18, 2013

Study Start

September 1, 2006

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

September 18, 2013

Record last verified: 2013-09

Locations

DK(1)