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

N/ANot Yet RecruitingNCT07619677

Universidad Autónoma de Bucaramanga100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Diabete Type 2 Diabetes Education

Interventions

Education and couselingOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adults (18 years or older). 2. Diagnosis of type 2 diabetes mellitus (DM) or arterial hypertension (HTN) (or both), documented in the medical record. 3. Prescription of pharmacological treatment for the condition. 4. Enrollment in a cardiovascular or metabolic risk program and scheduled for a medical follow-up visit within the next 3 to 6 months. Exclusion Criteria: * Mental disorders that impair autonomy or understanding of the interventions. * Congestive heart failure, ischemic or valvular heart disease, end-stage renal disease requiring dialysis, chemotherapy treatment, autoimmune diseases, recent hospitalization due to disease decompensation (within the last month), or any other condition preventing the patient from receiving general health recommendations according to their primary diagnosis. * Physical limitations such as quadriplegia, total loss of motor function, or contraindications to physical activity as indicated by medical prescription.

Outcomes

Primary Outcomes

Disease control

Disease control will be defined as: * For DM: Rate of patients with HbA1c within target range. * For HTN: Rate of patients with systolic blood pressure (SBP) and diastolic blood pressure (DBP) within target ranges.

Time frame: From enrollment to the end of intervention at 6 months

Medication adherence

Medication adherence: Rate of patients with medication adherence. Medication adherence will be measured using the Morisky-Green questionnaire (short version, 4 items), which has been validated in previous studies in populations with chronic conditions in the Colombian context.