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Feasibility of a Person-centered Nursing Intervention on Adherence and Control in Patients With Arterial Hypertension and Diabetes Mellitus.

NCT07619677 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-06-04

No results posted yet for this study

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.

Conditions

  • Diabete Type 2
  • Diabetes Education
  • Hypertension Arterial

Interventions

OTHER

Education and couseling

A nursing consultation to engage with the patient around what matters to them and co-create a goal-oriented education plan. The individualized plan with educational and counseling interventions will include up to six content domains: 1. Disease pathophysiology and treatment 2. Healthy diet and nutrition 3. Physical activity 4. Medication use 5. Health monitoring and follow-up 6. Prevention, detection, and management of complications The educational and counseling content will be based on the general recommendations for the management of HTN and DM included in the clinical practice guidelines of the Colombian Ministry of Health and Social Protection, respectively. Patients will be able to choose the domains of counseling according to their interests and preferences, as well as the modality and frequency through which they wish to receive the intervention.

Sponsors & Collaborators

  • Fundación Oftalmológica de Santander. Santander, Colombia

    collaborator OTHER

  • Universidad Autónoma de Bucaramanga

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-01-31
Completion
2027-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07619677 on ClinicalTrials.gov