Feasibility of a Person-centered Nursing Intervention on Adherence and Control in Patients With Arterial Hypertension and Diabetes Mellitus. (CERCANO pilot)
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.
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Skarlet Marcell Vásquez, RN, MSc
- Numero di telefono: 573012850414
- Email: svasquez196@unab.edu.co
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Person-centered nursing intervention
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:
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. |
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.
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Nessun intervento: Usual care
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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Disease control
Lasso di tempo: From enrollment to the end of intervention at 6 months
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Disease control will be defined as:
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From enrollment to the end of intervention at 6 months
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Medication adherence
Lasso di tempo: From enrollment to the end of intervention at 6 months
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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.
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From enrollment to the end of intervention at 6 months
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 35046441 (Identificatore di registro: ID-UNAB)
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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