The OPTIMAAL study: Shared decision making between patients and GPs in the treatment of type 2 diabetes in primary care.

The OPTIMAAL study: Shared decision making between patients and GPs in the treatment of type 2 diabetes in primary care. - OPTIMAAL: shared decision making in type 2 diabetes in primary care

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37364

Enrollment

250

Registered

2012-02-07

Start date

2012-03-16

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adult onset diabetes type 2 diabetes mellitus

Interventions

In the intervention group (with the SDM approach) patient and GP use a decision aid to discuss the pros and cons of two evidence based treatment possibilities: treatment according to the Dutch Colle

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Former participant in the ADDITION-Netherlands RCT; informed consent OR: Similar patients with T2DM, age between 60 and 80 years, diabetes duration of 8 to 15 year, who are not detected by screening; Informed consent

Exclusion criteria

Exclusion criteria: A history of alcoholism, drug abuse, psychosis, personality disorder or another emotional, psychological or intellectual problem that is likely to invalidate informed consent, or limit the ability of the individual to comply with the protocol requirements; A limited life expectancy.

Design outcomes

Primary

Measure	Time frame
The percentage of patients that achieve all individualised treatment targets form the SDM group compared with the control group.	—

Secondary

Measure	Time frame
- Blood pressure, total cholesterol, HbA1C, smoking habits and weight; - Satisfaction with the diabetes treatment, quality of life and well-being, health outcome and functional health, coping style; - Level of SDM knowledge/attitude of the GPs in the intervention group; - What are the indepent predictors of the patients who achieve the treatment targets? - Can we indentify the patients in the SDM group who show better results compared to others?	—

Measure

Time frame

- Blood pressure, total cholesterol, HbA1C, smoking habits and weight; - Satisfaction with the diabetes treatment, quality of life and well-being, health outcome and functional health, coping style; - Level of SDM knowledge/attitude of the GPs in the intervention group; - What are the indepent predictors of the patients who achieve the treatment targets? - Can we indentify the patients in the SDM group who show better results compared to others?

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)