To improve BP control and health related quality of life by offering a nurse-led patient-centred supportive intervention to people with T2DM who are objectively non-adherent to their antihypertensive medication and/or life style behaviour…
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
More than 75% of people with type 2 diabetes mellitus (T2DM) have an elevated
blood pressure (BP). Tight BP control decreases their risk of micro- and
macrovascular complications and cardiovascular death. To achieve good BP
control, medication adherence is crucial and multiple drug therapy often
unavoidable. However, polypharmacy, (assumed) adverse effects and suboptimal
health care provider-patient communication hamper adherence to antihypertensive
medication. At least 30% of all people with T2DM have a BP above target.
Therefore people*s beliefs about medications* effectiveness and adverse effects
should be discussed during diabetes monitoring visits. Guidelines advocate
discussing medication adherence and shared decision making, but they do not
provide an approach for this. We design and assess a practical stepwise
personalised approach to improve BP control in people with T2DM.
Study objective
To improve BP control and health related quality of life by offering a
nurse-led patient-centred supportive intervention to people with T2DM who are
objectively non-adherent to their antihypertensive medication and/or life style
behaviour influencing bloodpressure
Study design
Cluster randomised controlled trial (RCT) with 3 trial arms:
1: intervention group 1: blood test + results + intervention
2: intervention group 2: blood test + results + care-as-usual
3. control group: blood test, results after the trial period + care-as-usual
Intervention
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, analysis will be performed
immediately, and the results will be announced to the patient's physician and
the patient. In the care-as-usual trial arm, blood samples will be stored, and
analysis will be performed and results will be announced after the trial period
(12 months)
The intervention exists of three nurse-led sessions during 6 months, during the
regular diabetes consultations, in close collaboration with the general
practitioner or internist. Training of the nurses will focus on illness
perceptions, medication use, life style behaviour, socio-economic factors
influencing blood pressure and health behaviour. By using a decision aid that
visualizes the benefits and harms of bloodpressure control, shared decisions
and targets will be made on bloodpressre, related lifestyle changes and/or
prescribed medication. Patients wil be trained to improve their health
behaviour based on these targets.
Questionnaires concerning adherence perceptions, medication use, life style
behaviour, qualitiy of life wil be recorded. Blood pressure will be monitored
using a 30 minute blood pressure measurement.
Parallel to the intervention group, the two control arms with refractoy
hypertension will be asked to fill in the same questionnaires as the
intervention groups. Blood pressure will be monitored using the 30 minute
measurement. These groups recieve care as usual.
Study burden and risks
We will measure adherence at baseline and 12 months after formal inclusion. We
will determine adherence objectively from plasma samples (see preliminary
results for details) and subjectively by the validated Medication Adherence
Report Scale 5 (MARS-5). Other measurements (questionnaires: physical activity
and salt/ alcohol intake (self-report) BIPQ (9 items); BMQ (19 items); WHO-5 (5
items); EQ-5D/VAS (6 items)) will take place in all participants at baseline, 6
months and 12 months after the baseline visit. Other data will be extracted
from the patient medical records. In total three sessions of patient-centred
support by a trained nurse will be provided during 6 months. These sessions are
provided during the care-as-usual consultation moments in an independent health
center.
Turfmarkt 99
Den Haag 2511DP
NL
Turfmarkt 99
Den Haag 2511DP
NL
Listed location countries
Age
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
1. type 1 diabetes;
2. eGFR < 30 ml/min;
3. a history of alcoholism or drug abuse;
4. dementia or major psychiatric disorder that is likely to invalidate informed consent (IC), or limit the ability of the individual to comply with the protocol requirements.
5. Unwillingness to provide a written informed consent.
6. Pregnancy
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL68122.098.18 |