Nurse-led intervention to improve medication adherence in older adults with hypertension in primary care
| ISRCTN | ISRCTN35559821 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35559821 |
| Ethics committee reference number | PI_2023/92 |
| Sponsor | Department of Health of the Government of Navarra (Spain) |
| Funder | Department of Health of the Government of Navarra (Spain) |
- Submission date
- 01/01/2026
- Registration date
- 02/01/2026
- Last edited
- 05/01/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Alcibiades Segundo Diaz Vera
Principal investigator, Public, Scientific
Principal investigator, Public, Scientific
AV. PIO XII, 6, 6 A
Pamplona
31007
Spain
 ORCID ID |
0000-0002-3715-1713 |
|---|---|
| Phone | +34 (0)617321081 |
| as.diaz.vera@navarra.es |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Blinded (masking used) | |
| Control | Historical | |
| Assignment | Parallel | |
| Purpose | Diagnostic, Health services research, Prevention, Treatment | |
| Scientific title | Efficacy of the implementation of a nurse-led adherence protocol in older patients with hypertension in primary care centres | |
| Study acronym | NURSE-ADHERE-HTN | |
| Study objectives | The primary objective is to evaluate whether a nurse-led mixed educational and behavioural intervention improves medication adherence compared with usual care in adults aged 60 years and older with hypertension in primary care. Secondary objectives are to assess the effect of the intervention on blood pressure control, health-related quality of life, and use of healthcare services (emergency department visits and hospital admissions) at 6 and 12 months; to explore sociodemographic and clinical factors associated with medication adherence, including sex-specific differences; to screen for symptoms of anxiety and depression using the Goldberg Anxiety and Depression Scale; and to evaluate whether the effectiveness of the nurse-led intervention on medication adherence, health-related quality of life, and cardiovascular morbidity outcomes (emergency department visits and hospital admissions) at 6 and 12 months differs by sex/gender (effect modification analysis). An additional secondary objective is to explore the association between symptoms of anxiety and depression and medication adherence. | |
| Ethics approval(s) |
Approved 23/08/2023, Navarra Clinical Research Ethics Committee (CEIm) (Irunlarrea Street, 3, Pamplona, 31008, Spain; +34 (0)848 42 24 95; ceicnavarra@navarra.es), ref: PI_2023/92 | |
| Health condition(s) or problem(s) studied | Hypertension | |
| Intervention | Randomisation will be performed at the level of the nursing professional (cluster randomisation). Within each participating primary care centre, nurses will be randomly allocated in a 1:1 ratio to either the intervention group or the control group (usual care). All eligible patients under the care of each nurse will be assigned to the same study arm as their nurse. The randomisation sequence will be generated centrally using a computer-generated random allocation sequence. Due to the nature of the intervention, blinding of nurses and patients is not feasible; however, outcome assessment will be performed using standardised instruments and routinely collected clinical data. A nurse-led mixed educational and behavioural intervention delivered in primary care, consisting of: 1. Training of nursing professionals in medication adherence and motivational interviewing 2. Structured motivational interview with patients 3. Systematic medication review 4. Lifestyle counselling (diet, physical activity, smoking, alcohol) 5. Reinforcement through telephone calls and home visits Duration of patient follow-up: 12 months | |
| Intervention type | Mixed | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
These outcomes (blood pressure control, health-related quality of life, cardiovascular-related emergency department visits and hospital admissions, and medication adherence based on pharmacy refill data) will also be analysed to evaluate whether the effectiveness of the intervention differs by sex/gender (effect modification analysis). | |
| Completion date | 30/12/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 60 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 280 |
| Total final enrolment | 320 |
| Key inclusion criteria | 1. Age ≥60 years 2. Diagnosis of arterial hypertension 3. Prescribed antihypertensive medication 4. Non-adherence (Morisky–Green score ≥1) 5. At least one primary care visit in the previous year 6. Written informed consent |
| Key exclusion criteria | 1. Institutionalised patients 2. Life expectancy <12 months 3. Cognitive or physical conditions preventing participation |
| Date of first enrolment | 23/08/2023 |
| Date of final enrolment | 23/08/2026 |
Locations
Countries of recruitment
- Spain
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
05/01/2026: The secondary outcomes were updated.
02/01/2026: Study's existence confirmed by the Navarra Clinical Research Ethics Committee (CEIm).
