ISRCTN - ISRCTN84636255: Efficacy of an evidence-based Informed Shared Decision Making program for prevention of myocardial infarction in type 2 diabetes

Plain English Summary

Background and study aims
Cardiovascular disease is the predominant life threatening complication related to type 2 diabetes. An array of behavioural directives is imposed on persons with type 2 diabetes, such as quitting smoking, increasing exercise, normalizing weight, and adhering to monitoring, dietary and medication prescriptions. Evidence on effectiveness of these interventions is varying and some may even do more harm than good. Patients frequently feel demotivated and overloaded by the pure number of medical prescriptions. This might contribute to poor long-term adherence even to the most effective preventative interventions. The overall objective is to improve the quality of decision-making by enhancing patients' understanding and their ability to deliberate between the available preventative options, and by supporting them to participate in decision-making more actively. An informed shared decision making program was developed. The program consists of a decision aid booklet and a corresponding counselling module provided by diabetes educators. It comprises current easy to understand evidence-based information media. The specific aim of this study is to investigate the efficacy of this informed shared decision making program. We will evaluate, if patients who attend the program estimate their heart attack risk realistically, understand benefits and harms of the preventative options, and are more adherent to their decisions.

Who can participate?
A total of 154 men and women with type 2 diabetes will be recruited, aged between 40 and 69 years, with no previous heart attack or other cardiovascular disease.

What does the study involve?
Two study groups will be compared: The intervention group will receive the informed shared decision making program; the control group will receive placebo counselling, i.e. a program which is similar in structure and differs in the provided content. Both counselling programs take 90 minutes. Two weeks before the counselling the patients will be asked to read and work through information material.

What are the possible benefits and risks of participating?
Participants will receive information and a new kind of counselling, which may result in a higher motivation to deliberate pros and cons of the available preventative options and make informed decisions. This might also influence the communication between patients and care providers.
There are no known risks associated with participating in the study. The information provided within the counselling intervention is consistent with current scientific evidence and has been developed by a team of researchers and diabetes experts. Trained diabetes educators provide the counselling. The counselling strategy reflects current educational practice.

Where is the study run from?
The study is a joined venture of the Unit of Health Science and Education at the University of Hamburg and the Jena University Medical Centre, in Germany. Study site is the Clinic for Endocrinology and Metabolic Diseases of the University Medical Centre Jena.

When is the study starting and how long is it expected to run for?
The study will start in March 2013 and will have a follow-up of six months. Recruitment of participants will need about three months.

Who is funding the study?
European Foundation for the Study of Diabetes

Who is the main contact?
Ms Susanne Buhse
susanne.buhse@uni-hamburg.de

Trial website

http://www.diabetes-und-herzinfarkt.de/

Contact information

Type

Scientific

Primary contact

Ms Susanne Buhse

ORCID ID

Contact details

Universität Hamburg
MIN Fakultät
Gesundheitswissenschaft
Martin-Luther-King-Platz 6
Hamburg
20146
Germany
-
susanne.buhse@uni-hamburg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Efficacy of an evidence-based Informed Shared Decision Making program for prevention of myocardial infarction in type 2 diabetes: a randomised controlled trial

Acronym

ISDM

Study hypothesis

We hypothesize that patients who attend the Informed Shared Decision Making (ISDM) program estimate their heart attack risk realistically, understand benefits and harms of the preventative options, and are more adherent to their decisions.

The registration was initiated on 22/02/2013 and finalised on 12/04/2013. Following the prospective submission on 22/02/2013, there were no subsequent changes to the protocol. The recruitment started on 12/03/2013, after initiation of public registration.

On 29/05/2015 the overall trial end date was changed from 12/12/2013 to 01/03/2015.

Ethics approval

Ethics committee of the Friedrich-Schiller-University, Jena, 27/09/2011

Study design

Parallel group two-arm single-blinded randomized controlled superiority trial with 6 months of follow-up

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Patient information can be found at http://www.diabetes-und-herzinfarkt.de/wp-content/uploads/20130220_Phase-2-PatInfo.pdf

Condition

Evidence-based patient information on the prevention of heart attack in type 2 diabetes

Intervention

Two study groups will be compared:

Intervention group: ISDM program consisting of a decision aid booklet and a curriculum for group counseling.

Control group: Placebo counseling, i.e. a program similar in structure and different in the provided content.

Each counselling program consists of one session taking 90 minutes. Two weeks before the counselling the patients will be asked to read and work through information material.

Follow up: 6 months

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The patients' comprehension of heart attack prevention that includes the understanding of the concept of risk, the notion of heart attack risk, and the benefits and harms of preventative measures.

Secondary outcome measures

1. Adherence to the individual treatment goals regarding statin treatment, blood-pressure treatment, glucose control, and smoking cessation
2. Adherence to the preventative option prioritized by the individual patient

Overall trial start date

12/03/2013

Overall trial end date

01/03/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients (men and women) are eligible with type 2 diabetes
2. Aged between 45 and 69 years
3. With no previous diagnosis of ischemic heart disease (ICD I20-I25)
4. With former participation in Decision Making (DMP) education programs for type 2 diabetes
5. HbA1c-values between 6 and 9%

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

154 patients with type 2 diabetes

Participant exclusion criteria

Patients will be excluded if they have:
1. Cognitive disorders
2. Proliferative retinopathy
3. Chronic kidney disease stage three or higher [Kidney Disease Outcomes Quality Initiative (KDOQI)]
4. Addiction to alcohol
5. Metastatic cancer

Recruitment start date

12/03/2013

Recruitment end date

01/06/2014

Locations

Countries of recruitment

Germany

Trial participating centre

Universität Hamburg
Hamburg
20146
Germany

Sponsor information

Organisation

European Foundation for the Study of Diabetes (EFSD) (Germany)

Sponsor details

EFSD Office
Rheindorfer Weg 3
Düsseldorf
40591
Germany
-
foundation@easd.org

Sponsor type

Charity

Website

http://www.europeandiabetesfoundation.org/

Funders

Funder type