NCT03105687

Brief Summary

By conducting the SPPA trial we try to find out, whether personalized Short Message Service (SMS) reminders of blood pressure-lowering medication can effectively increase patients' adherence to blood pressure-lowering medication. Additionally, we also evaluate their effect on patients' systolic blood pressure control.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 16, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2018

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

7 months

First QC Date

March 17, 2017

Last Update Submit

February 14, 2018

Conditions

HypertensionPrimary HypertensionNon-Adherence, MedicationNon-Adherence, Patient

Keywords

mHealthSMS remindersadherenceantihypertensive drugspharmacistscost-effectiveness

Outcome Measures

Primary Outcomes (1)

  • Combined adherence endpoint

    Measurement variable: adherence status (dichotomous) assessed via the eight item Morisky Medication Score (MMAS-8) as follows: adherent: MMAS-8 score ≥6 and pill count rate ≥80% or \<=120% non-adherent: MMAS-8 score \<6 and/or pill count rate \<80% or \>120% Analysis Metric: final value (Visit 2) Method of aggregation: proportion of adherent patients (%)

    at Visit 2 (follow-up visit after 3 months of intervention period)

Secondary Outcomes (4)

  • Change in medians of MMAS-8 after 3 months

    at Visit 2 (at follow-up visit; 3 months after Visit 1)

  • Mean Adherence Rate (%) after 3 months calculated via pill count

    at Visit 2 (at follow-up visit; 3 months after Visit 1)

  • Mean change in systolic BP after 3 months

    at Visit 2 (at follow-up visit; 3 months after Visit 1)

  • Patients' satisfaction with SMS reminders.

    at Visit 2 (at follow-up visit; 3 months after Visit 1)

Other Outcomes (4)

  • Overall direct treatment costs

    at Visit 2 (at follow-up visit; 3 months after Visit 1)

  • Signals of adverse events associated with blood pressure-lowering medication

    at Visit 2 (at follow-up visit; 3 months after Visit 1)

  • Number of patients who refused to participate in the study (Patients Refusal Rate)

    Trough enrollment

  • +1 more other outcomes

Study Arms (2)

Control

NO INTERVENTION

Participants in the Control group will receive standard Pharmaceutical Care according to the principles of Good Pharmaceutical Practice and national Slovak legislation requirements only. Participants in the control group will also receive a welcome SMS one day after enrollment and an end-of-trial SMS three months after the enrollment. Additionally, prior to their scheduled follow-up visit (Visit 2), three months following the enrollment, trial pharmacists will call the participants to remind them of their follow-up visit.

Intervention

EXPERIMENTAL

Participants in the intervention group will also receive standard Pharmaceutical Care provided by the trial pharmacist, the welcome SMS and the end-of-trial SMS. Additionally, they will receive daily SMS reminders of their blood pressure-lowering medication intake from a trial pharmacist for a period of 3 months after the enrollment. The structure of the SMS reminder will follow the information provided as a part of the usual drug dispensation and counselling process as described in the Slovak national Decree No. 129/2012 Coll. Thus, most of the data are available on the prescription and all of the collected data are already a well-established and required part of the standard Pharmaceutical Care in Slovakia. The simple structure of the SMS reminder will allow for future reproducibility.

Behavioral: SMS reminders of medicines intake

Interventions

SMS reminders of medicines intakeBEHAVIORAL

The intervention consists of daily SMS reminders of blood pressure-lowering medication provided by a pharmacist for a period of 3 months.

Intervention

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 55 years (from the day of the 55. birthday inclusive)
  • Diagnosis of primary (essential) hypertension (I10 according to International Classification of Diseases (ICD-10))
  • Filling of blood pressure-lowering prescription(s) at trial recruitment (Visit 1)
  • Duration of antihypertensive drug treatment for at least 1 year without any discontinuation
  • Ownership of a mobile phone for personal use with the ability to open and read SMS
  • Understanding of Slovak language on native-speaker level
  • Informed consent for participation in the clinical trial and personally signed Informed Consent Form

You may not qualify if:

  • Planned hospitalisation during the trial period (3 months)
  • Biological impairment affecting the ability to read the SMS (e.g. loss of vision, visual field cuts, aphasia)
  • Living in the same household with another trial participant
  • Participation in another clinical trial
  • Hospitalisation during the trial period
  • Patient informs he/she won't be able to participate in the trial
  • Withdrawal of Informed Consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Lekáreň Needham

Banská Bystrica, Slovakia

Location

Lekáreň V KAUFLANDE BB, s.r.o.

Banská Bystrica, Slovakia

Location

Lekáreň DANUBIA

Bratislava, Slovakia

Location

Lekáreň Dr.Max 12

Bratislava, Slovakia

Location

Lekáreň Poliklinika Šustekova

Bratislava, Slovakia

Location

Lekáreň GREEN-STRAP

Dubnica nad Váhom, Slovakia

Location

Lekáreň Námestie Matice Slovenskej, Dr. Max

Dubnica nad Váhom, Slovakia

Location

Lekáreň Dr.Max 90, Nemocnica s poliklinkou Sv.Lukáša

Galanta, Slovakia

Location

Lekáreň REDMOON

Hnúšťa, Slovakia

Location

Lekáreň 17

Kežmarok, Slovakia

Location

Lekáreň Námestie Osloboditeľov, Dr. Max

Liptovský Mikuláš, Slovakia

Location

Lekáreň RED-MARKET s.r.o.

Malacky, Slovakia

Location

Lekáreň PRED NEMOCNICOU

Martin, Slovakia

Location

Lekáreň, OC Tulip

Martin, Slovakia

Location

Lekáreň Námestie Slobody, Dr. Max

Piešťany, Slovakia

Location

Lekáreň HEALTHSTORE

Prešov, Slovakia

Location

Lekáreň Dr.Max 22

Rimavská Sobota, Slovakia

Location

Lekáreň Dr.Max 36

Rožňava, Slovakia

Location

Lekáreň OC Madaras Dr. Max

Spišská Nová Ves, Slovakia

Location

Lekáreň EURO FARMÁCIA s.r.o.

Trenčín, Slovakia

Location

Lekáreň SD5 s.r.o.

Trenčín, Slovakia

Location

Lekáreň CASTILION

Vranov nad Topľou, Slovakia

Location

Železničná Lekáreň

Zvolen, Slovakia

Location

Lekáreň Bernolákova, Dr. Max

Žilina, Slovakia

Location

Related Publications (2)

  • Haramiova Z, Stasko M, Hulin M, Tesar T, Kuzelova M, Morisky DM. The effectiveness of daily SMS reminders in pharmaceutical care of older adults on improving patients' adherence to antihypertensive medication (SPPA): study protocol for a randomized controlled trial. Trials. 2017 Jul 18;18(1):334. doi: 10.1186/s13063-017-2063-8.

    PMID: 28720121BACKGROUND

  • Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3.

    PMID: 33769555DERIVED

Related Links

MeSH Terms

Conditions

HypertensionEssential HypertensionMedication AdherencePatient Compliance

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Zuzana Haramiova, PharmDr.

    Faculty of Pharmacy Comenius University in Bratislava, Department of Organization and Management of Pharmacy

    STUDY DIRECTOR

  • Magdalena Kuzelova, Prof., PharmDr., PhD.

    Faculty of Pharmacy Comenius University in Bratislava, Department of Pharmacology and Toxicology

    STUDY CHAIR

  • Donald M. Morisky, Sc.D., M.S.P.H., Sc.M.

    Fielding School of Public Health, Department of Community Health Sciences

    STUDY CHAIR

  • Tomas Tesar, Doc., PharmDr., PhD, MBA

    Faculty of Pharmacy Comenius University in Bratislava, Department of Organization and Management of Pharmacy

    STUDY CHAIR

  • Michal Stasko, PharmDr.

    Faculty of Pharmacy Comenius University in Bratislava, Department of Organization and Management of Pharmacy

    STUDY CHAIR

  • Martin Hulin, Ing., Mgr., PhD.

    Research Institute for Child Psychology and Pathopsychology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PharmDr.

Study Record Dates

First Submitted

March 17, 2017

First Posted

April 10, 2017

Study Start

June 16, 2017

Primary Completion

January 10, 2018

Study Completion

February 14, 2018

Last Updated

February 19, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will share

All collected data will be anonymized and made available on via Open Science Framework

Locations

SL(24)