Effectiveness and Cost-Effectiveness of a Digital Care Pathway and Asynchronous Communication for Patients With Hypertension (DEPTH)
Digital Care Pathway and Asynchronous Communication for Primary Care Patients With Uncontrolled Hypertension: a Cluster-Randomized Controlled Trial
The goal of this clinical trial is to learn if digital care pathway (DCP) and digital non-real-time messaging, in other words, asynchronous communication (AC) with nurse works to treat high blood pressure in adults in primary care. It will also learn if DCP and AC are good value for money. The main questions it aims to answer are:
- Does DCP and AC lower systolic blood pressure?
- Are DCP and AC good value for money in treating high blood pressure? Researchers will compare usual care plus DCP and usual care plus DCP with AC to usual care only to see if DCP and AC works to treat high blood pressure.
Participants will:
- Get usual care or usual care plus DCP or usual care plus DCP with AC for 6 months
- Visit the study nurse at the start of the trial and after 6 months for checkup and tests which include usual laboratory tests for high blood pressure
- Answer online survey questions and measure their blood pressure at home for 4 days at the start of the trial and after 6 months
Přehled studie
Postavení
Podmínky
Detailní popis
The study will be conducted as a prospective, cluster-randomized controlled trial in six primary healthcare centres within the Wellbeing Services County of Pirkanmaa, Finland. Randomization will be performed at the healthcare centre level, with two centres allocated to each study arm. Because of the nature of the interventions, neither participants nor healthcare professionals can be blinded to treatment allocation.
Before the study begins, one induction session will be organised at all participating healthcare centres. This session will give healthcare professionals information about the study protocol and recommendations for hypertension management. In addition, professionals working at centres allocated to the intervention arms will receive training in the use of the digital care pathway and asynchronous communication.
One nurse from each participating centre will be appointed as a part-time study nurse. The study nurses will be responsible for participant recruitment, conducting baseline and follow-up visits, and promoting study awareness within their respective healthcare centres. During the study, participants will be monitored either by the study nurse or by other healthcare professional familiar with the participant. Hypertension management is optimised in accordance with the participant's home blood pressure readings.
Participants will be recruited for the study over a period of 6-12 months. Data will be collected at baseline and at the end of the 6 month follow-up. Data sources will include study nurse assessments during study visits, electronic health records and registers of the Wellbeing Services County of Pirkanmaa, the digital care pathway, and electronic questionnaires via the REDCap digital research platform.
Based on power calculations, assuming a statistical power of 80 percent and a two-sided significance level of 0.05, a minimum of 182 participants per study arm is required to detect a between-group difference of at least 5 mmHg in the change in systolic blood pressure during follow-up (SD of change in systolic blood pressure 17 mmHg). Considering cluster randomization and participant dropout during follow-up, the target sample size is 200 participants per study arm, resulting in a total sample size of 600 participants.
The results will be presented as means and standard deviations (SDs) for continuous variables, and frequencies and percentages for categorical variables. Between-group comparisons will be conducted using Student's t-test for normally distributed continuous variables, the Mann-Whitney U test for non-normally distributed continuous variables, and Pearson's chi-squared test or Fisher's exact test for categorical variables. The effects of the interventions on change in systolic blood pressure will be analysed using regression-based methods that account for the clustered study design, such as linear mixed-effects model. According to the intention-to-treat principle, all participants recruited to the study will be included in the primary analyses, regardless of whether they remained in the study for the entire follow-up period. A two-sided p-value of less than 0.05 will be considered statistically significant. All statistical analyses will be performed using IBM SPSS Statistics software.
The cost-effectiveness of the interventions will be assessed by calculating the incremental cost-effectiveness ratio (ICER), based on differences in both costs and effectiveness between the study arms. Costs will be assessed from the healthcare system perspective.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Teemu Ekola, MD
- Telefonní číslo: +358444863415
- E-mail: teemu.ekola@tuni.fi
Studijní místa
-
-
Pirkanmaa
-
Akaa, Pirkanmaa, Finsko
- Akaa health and social services centre, The Wellbeing Services County of Pirkanmaa
-
Kontakt:
- Teemu Ekola, MD
- Telefonní číslo: +358444863415
- E-mail: teemu.ekola@tuni.fi
-
Vrchní vyšetřovatel:
- Tuomas Koskela, Professor
-
Sastamala, Pirkanmaa, Finsko
- Sastamala health and social services centre, The Wellbeing Services County of Pirkanmaa
-
Kontakt:
- Teemu Ekola, MD
- Telefonní číslo: +358444863415
- E-mail: teemu.ekola@tuni.fi
-
Vrchní vyšetřovatel:
- Tuomas Koskela, Professor
-
Tampere, Pirkanmaa, Finsko
- Hatanpää health and social services centre, The Wellbeing Services County of Pirkanmaa
-
Kontakt:
- Teemu Ekola, MD
- Telefonní číslo: +358444863415
- E-mail: teemu.ekola@tuni.fi
-
Vrchní vyšetřovatel:
- Tuomas Koskela, Professor
-
Tampere, Pirkanmaa, Finsko
- Hervanta health and social services centre, The Wellbeing Services County of Pirkanmaa
-
Kontakt:
- Teemu Ekola, MD
- Telefonní číslo: +358444863415
- E-mail: teemu.ekola@tuni.fi
-
Vrchní vyšetřovatel:
- Tuomas Koskela, Professor
-
Tampere, Pirkanmaa, Finsko
- Linnainmaa health and social services centre, The Wellbeing Services County of Pirkanmaa
-
Kontakt:
- Teemu Ekola, MD
- Telefonní číslo: +358444863415
- E-mail: teemu.ekola@tuni.fi
-
Vrchní vyšetřovatel:
- Tuomas Koskela, Professor
-
Valkeakoski, Pirkanmaa, Finsko
- Valkeakoski health and social services centre, The Wellbeing Services County of Pirkanmaa
-
Kontakt:
- Teemu Ekola, MD
- Telefonní číslo: +358444863415
- E-mail: teemu.ekola@tuni.fi
-
Vrchní vyšetřovatel:
- Tuomas Koskela, Professor
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- a diagnosis of hypertension for at least 3 months
- an office blood pressure of ≥140/90 mmHg at baseline
- access to a smartphone and the ability to use strong electronic identification for application login
- ability to measure home blood pressure
- ability to take care of the personal medication
Exclusion Criteria:
- unwillingness to participate in the study
- secondary hypertension or hypertensive crisis (office blood pressure >200/130 mmHg)
- atrial fibrillation
- stage 4 or 5 chronic kidney disease (eGFR <30 mL/min/1.73 m²)
- a life expectancy of less than 1 year
- pregnancy or breastfeeding
- a clearly impaired ability to use the study interventions or participate in the study, as determined by a healthcare professional (e.g., insufficient Finnish language proficiency, dementia, psychiatric illness, or sensory impairments)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Žádný zásah: Control
Usual Care for hypertension
|
|
|
Experimentální: Digital Care Pathway
Usual Care + Digital Care Pathway for 6 months
|
Digital care pathway for hypertension is a web-based and mobile application that includes goal setting and education material for hypertension, entering home blood pressure values, medication list and medication intake, blood pressure self-test and self-care survey, reminders on measuring values, upcoming appointments and self-care guidance, motivational messages and diary.
|
|
Experimentální: Digital Care Pathway and Asynchronous Communication
Usual Care + Digital Care Pathway with Asynchronous Communication with nurse for 6 months
|
Digital care pathway for hypertension is a web-based and mobile application that includes goal setting and education material for hypertension, entering home blood pressure values, medication list and medication intake, blood pressure self-test and self-care survey, reminders on measuring values, upcoming appointments and self-care guidance, motivational messages and diary.
Asynchronous communication means digital bidirectional non-real-time messaging between participant and nurse.
It can be used with digital care pathway.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change from Baseline in the Office Systolic Blood Pressure Level at 6 Months
Časové okno: Baseline and 6 months
|
Office systolic blood pressure is measured using a validated and calibrated blood pressure monitor in accordance with the 2024 European Society of Cardiology (ESC) guidelines.
Three blood pressure measurements are taken by the study nurse during the office visit, and the average of the last two measurements is used as the participant's blood pressure level.
If the blood pressure readings differ by more than 10 mmHg, additional measurements are taken.
|
Baseline and 6 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change from Baseline in the Home Systolic Blood Pressure Level at 6 Months
Časové okno: Baseline and 6 months
|
Home systolic blood pressure is measured using a validated blood pressure monitor listed in the STRIDE BP database, in accordance with the Finnish Current Care Guidelines for Hypertension.
Participants measure their seated cuff blood pressure twice in the morning and twice in the evening for four consecutive days.
The home blood pressure level is defined as the mean of all recorded measurements.
|
Baseline and 6 months
|
|
Proportion of Participants with Controlled Blood Pressure at 6 months
Časové okno: 6 months
|
Controlled blood pressure is defined as an office blood pressure level <140/90 mmHg and a home blood pressure level <135/85 mmHg according to the Finnish Current Care Guidelines for Hypertension
|
6 months
|
|
Change from Baseline in the Cardiovascular Disease Risk at 6 Months assessed by FINRISKI risk calculator
Časové okno: Baseline and 6 months
|
The FINRISKI calculator is based on data on risk factors and morbidity follow-up from participants in the FINRISKI study conducted in 1982, 1987, 1992, 2002 and 2007.
Data on morbidity and mortality among study participants over the 10-year follow-up period were obtained from Finnish registers.
The FINRISKI calculator provides a percentage score that indicates participant's risk of suffering a heart attack or a stroke over the next 10 years.
The percentage ranges from 0 to 100 percent, and a higher value indicates a worse outcome.
|
Baseline and 6 months
|
|
Change from Baseline in the Cardiovascular Disease Risk at 6 Months assessed by Systematic Coronary Risk Evaluation 2 (SCORE2) risk calculator
Časové okno: Baseline and 6 months
|
The SCORE2 risk calculator provides an estimate of 10-year fatal and non-fatal cardiovascular disease risk for participants without previous CVD or diabetes aged 40-69 years in Europe.
It gives a percentage score that ranges from 0 to 100 percent, and a higher value indicates a worse outcome.
|
Baseline and 6 months
|
|
Change from Baseline in Quality of Life at 6 Months
Časové okno: Baseline and 6 months
|
Health related quality of life is measured with the EuroQoL-5D-5L questionnaire.
The EQ-5D-5L questionnaire consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Each dimension has 5 levels: 1 no problems, 2 slight problems, 3 moderate problems, 4 severe problems and 5 extreme problems.
The participant is asked to indicate his/her health state by ticking the box next to the most appropriate level in each of the five dimensions.
A higher level on each dimension indicates poorer health.
The EQ VAS records the participant's self-rated health on a vertical visual analogue scale where participant rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
|
Baseline and 6 months
|
|
Change from Baseline in Self-Care Preparedness Index at 6 Months
Časové okno: Baseline and 6 months
|
The Self-Care Preparedness Index is assessed by a questionnaire for participants.
The questionnaire contains six questions about participant's self-care.
The index ranges from -5 to +5.
A higher number indicates a higher level of self-care preparedness.
|
Baseline and 6 months
|
|
Change from Baseline in Medication Adherence at 6 Months
Časové okno: Baseline and 6 months
|
Medication adherence is assessed by reviewing antihypertensive medication prescriptions issued and dispensed during the preceding 6 months.
Prescription data will be obtained from the electronic health record system with the participant's consent.
More prescriptions dispensed as instructed by a doctor means better outcome.
The value can range from 0 percent of prescriptions dispensed to 100 percent prescriptions dispensed as instructed.
|
Baseline and 6 months
|
|
Participants' Perceptions of the Feasibility and Usability of DCP and AC assessed by a 5-point Likert Scale Questionnaire
Časové okno: 6 months
|
The questionnaire is developed based on the Unified Theory of Acceptance and Use of Technology 2 (UTAUT2) model.
The scale ranges from 1 (Totally disagree) to 5 (Totally agree).
|
6 months
|
|
Change from Baseline in Participant-Perceived Barriers to Hypertension Management at 6 Months
Časové okno: Baseline and 6 months
|
Participant-perceived barriers to hypertension management are assessed using a 5-point Likert scale questionnaire based on the model by Khatib et al (2014).
The scale ranges from 1 (Totally disagree) to 5 (Totally agree).
|
Baseline and 6 months
|
|
Number of Hypertension-Related Healthcare Contacts During Follow-Up
Časové okno: From baseline to 6 months
|
The number of participant's healthcare contacts related to hypertension will be assessed after a 6-month follow-up using registry data of the Wellbeing Services County of Pirkanmaa.
Healthcare contacts include all contacts (face-to-face and remote) with nurses and doctors at primary health care centers, as well as outpatient visits and inpatient hospital days in specialized healthcare.
|
From baseline to 6 months
|
|
Hypertension-Related Costs During Follow-Up
Časové okno: From baseline to 6 months
|
The costs will be assessed after a 6-month follow-up by multiplying participant's hypertension-related healthcare contacts with their unit costs obtained from the official price list of the Wellbeing Services County of Pirkanmaa.
All costs will be reported in euros (€).
|
From baseline to 6 months
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Tuomas Koskela, Professor, Chief Physician, Faculty of Medicine and Health Technology, Tampere University, Finland. The Wellbeing Services County of Pirkanmaa, Finland
Publikace a užitečné odkazy
Obecné publikace
- Khatib R, Schwalm JD, Yusuf S, Haynes RB, McKee M, Khan M, Nieuwlaat R. Patient and healthcare provider barriers to hypertension awareness, treatment and follow up: a systematic review and meta-analysis of qualitative and quantitative studies. PLoS One. 2014 Jan 15;9(1):e84238. doi: 10.1371/journal.pone.0084238. eCollection 2014.
- McEvoy JW, McCarthy CP, Bruno RM, Brouwers S, Canavan MD, Ceconi C, Christodorescu RM, Daskalopoulou SS, Ferro CJ, Gerdts E, Hanssen H, Harris J, Lauder L, McManus RJ, Molloy GJ, Rahimi K, Regitz-Zagrosek V, Rossi GP, Sandset EC, Scheenaerts B, Staessen JA, Uchmanowicz I, Volterrani M, Touyz RM; ESC Scientific Document Group. 2024 ESC Guidelines for the management of elevated blood pressure and hypertension. Eur Heart J. 2024 Oct 7;45(38):3912-4018. doi: 10.1093/eurheartj/ehae178. No abstract available.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- R25071
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .