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Optimal blood pressure control through improved adherence to antihypertensive medication after shared decision making in people with type 2 diabetes (T2DM)

Optimal blood pressure control through improved adherence to antihypertensive medication after shared decision making in people with type 2 diabetes (T2DM) - INTENSE

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45993
Enrollment
264
Registered
2018-12-31
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

type 2 diabetes

Interventions

After inclusion a bloodtest will be performed at T=0 months and T= 12 months, for the measurement of the serum antihypertensive level, to objectify medication non-adherence. In 2 trial arms, analysi

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Adults (>18 years) with T2DM AND 2. BP >140/90 mm Hg ( people * 80 years) or > 160/90 mmHg (people > 80 years, based on Dutch guidelines), measured during the last-check up at the general practice/ endocrinologist using a 30-minute bloodpressure monitor. AND 3. use of three adequately dosed antihypertensive medications, including a diuretic during at least the past 3 months

Exclusion criteria

Exclusion criteria: 1. type 1 diabetes; 2. eGFR

Design outcomes

Primary

MeasureTime frame
The difference in blood pressure between groups after 12 months. The effect of a measurement of the antihypertensive serum level to objectify adherence to medication on the blood pressure after 12 months

Secondary

MeasureTime frame
What is the effect of a theory driven nurse-led patient-centred approach, including a decision aid for hypertensive, non-adherent individuals with T2DM and uncontrolled BP on: 1. Body weight 2. Number of smokers that quit smoking 3. adherence to physical exercise guidelines 4. adherence to nutrition guidelines (salt, vegetable, alcohol intake) 5. BP and the proportion of people that achieve their personalised treatment target based on SDM; 6. Antihypertensive medication adherence; 7. Reasons for non-adherence 8. Prescribed medication; 9. Beliefs about medication and Illness perceptions; 10. Health related quality of life; 11. Health related costs (cost-effectiveness). 12. Number of referrals to secondary care

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)