Diabete Type 2CERCANO pilotNCT07619677
Feasibility of a Person-centered Nursing Intervention on Adherence and Control in Patients With Arterial Hypertension and Diabetes Mellitus.
A study testing Education and couseling in people with Diabete Type 2 and Diabetes Education, run by Universidad Autónoma de Bucaramanga.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabete Type 2, Diabetes Education, Hypertension Arterial
- What is being tested?
- Education and couseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility of a Person-centered Nursing Intervention on Adherence and Control in Patients With Arterial Hypertension and Diabetes Mellitus. CERCANO Pilot Trial.
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.
Read more
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
- Being tested
- Education and couseling
- Keywords
- Person-centered care, Hypertension, Diabetes type 2, Control, Adherence, Nursing interventions, Education
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to the end of intervention at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autónoma de Bucaramanga
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Oftalmológica de Santander. Santander, Colombia
- Responsible party
- Principal investigator, Skarlet Marcell Vasquez Hernandez, Universidad Autónoma de Bucaramanga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619677
- Sponsor's protocol ID
- 35046441
- Other IDs
- 35046441
- Acronym
- CERCANO pilot
- Status last verified
- Jun 2026
- First submitted
- 26 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This alternative was not approved by the ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Person-centered Nursing Intervention on Adherence and Control in Patients With Arterial Hypertension and Diabetes Mellitus. CERCANO Pilot Trial.
- ClinicalTrials.gov ID
- NCT07619677
- Acronym / sponsor ID
- CERCANO pilot / 35046441
- Conditions
- Diabete Type 2, Diabetes Education, Hypertension Arterial
- Keywords
- Person-centered care, Hypertension, Diabetes type 2, Control, Adherence, Nursing interventions, Education
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad Autónoma de BucaramangaUniversity, hospital or other
- Collaborators
- Fundación Oftalmológica de Santander. Santander, Colombia
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Person-centered nursing intervention | Experimental | Other: Education and couselingA 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education and couselingA 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. | Other | Person-centered nursing intervention |
Primary outcome
Disease control
Time frame: From enrollment to the end of intervention at 6 months
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.
Medication adherence
Time frame: From enrollment to the end of intervention at 6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No. This alternative was not approved by the ethics committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Education and couseling in people with Diabete Type 2 and Diabetes Education, run by Universidad Autónoma de Bucaramanga.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Skarlet Marcell Vásquez, RN, MSc (573012850414, svasquez196@unab.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control (time frame: From enrollment to the end of intervention at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.