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

NCT07619677 | Not Yet Recruiting

• 1 other identifier: 35046441
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Person-centered care; Hypertension; Diabetes type 2; Control; Adherence; Nursing interventions; Education

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From enrollment to the end of intervention at 6 months

Study Arms (2)

Person-centered nursing intervention

EXPERIMENTAL

A nursing consultation to engage with the patient around what matters to them and co-create a goal-oriented educationand counseling 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.

Other: Education and couseling

Usual care

NO INTERVENTION

Patients assigned to the control group will receive usual care interventions provided within the cardiovascular/metabolic risk programs to which they belong at each participating healthcare institution.

Interventions

Education and couseling OTHER

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.

Person-centered nursing intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autónoma de Bucaramanga: lead
• Fundación Oftalmológica de Santander. Santander, Colombia: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Central Study Contacts

Skarlet Marcell Vásquez, RN, MSc

CONTACT

573012850414; svasquez196@unab.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Faculty Researcher

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 2, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share