Feasibility of a Person-centered Nursing Intervention on Adherence and Control in Patients With A… (NCT07619677) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Feasibility of a Person-centered Nursing Intervention on Adherence and Control in Patients With Arterial Hypertension and Diabetes Mellitus.
100 participantsStarted 2026-06
Plain-language summary
Background. Approximately 80% of people with type 2 diabetes mellitus (DM) or arterial hypertension (HTN) do not achieve adequate disease control.
Objective. To evaluate the feasibility of a research study assessing the impact of an educational and nursing counseling intervention with a person-centered care (PCC) approach to improve adherence and control in patients with arterial hypertension and diabetes mellitus in Colombia.
Methods. A pilot randomized controlled clinical trial will be conducted. Adults with DM or HTN enrolled in cardiovascular or metabolic risk programs will be included. A total of 100-200 patients is expected to be recruited. The intervention group will receive counseling and education tailored to their preferences following the PCC approach, while the control group will receive standard care according to the program they belong to. Follow-up will last 6 months, and the primary outcomes to be measured in both groups are: medication adherence, DM control (HbA1c at target levels, change in HbA1c), and HTN control (SBP and DBP at target levels, changes in SBP and DBP).
Results. The findings of this study will provide insight into the feasibility of conducting larger-scale studies to evaluate the effectiveness of PCC-based interventions in Colombia.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults (18 years or older).
. Diagnosis of type 2 diabetes mellitus (DM) or arterial hypertension (HTN) (or both), documented in the medical record.
. Prescription of pharmacological treatment for the condition.
. Enrollment in a cardiovascular or metabolic risk program and scheduled for a medical follow-up visit within the next 3 to 6 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a person-centered nursing intervention for people who have both Type 2 diabetes and high blood pressure — does my current situation with managing both conditions make this something worth exploring?
2Since this study is still in a feasibility phase and hasn't started recruiting yet, what does that mean for how much is already known about whether this type of nursing intervention actually improves blood pressure and blood sugar control?
3The trial is focused on medication adherence — if I'm already struggling to stick to my current medications, could discussing this study with my care team help us figure out whether a more personalized approach might work better for me?
4Because this trial hasn't started recruiting yet, how long might it realistically be before I could even consider joining, and in the meantime, what standard options are available to help me manage both my diabetes and hypertension more effectively?
5This study involves a nursing-led intervention rather than a new drug — can you help me understand what that type of program typically looks like day-to-day, and how demanding it might be to participate alongside my regular care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Disease control
Timeframe: From enrollment to the end of intervention at 6 months
2
Medication adherence
Timeframe: From enrollment to the end of intervention at 6 months