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Effectiveness and Cost-Effectiveness of a Digital Care Pathway and Asynchronous Communication for Patients With Hypertension (DEPTH)

2026年9月3日 更新者：Wellbeing Services County of Pirkanmaa

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

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

600

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • フィンランド
    • Pirkanmaa
      • Akaa、Pirkanmaa、フィンランド
        • Akaa health and social services centre, The Wellbeing Services County of Pirkanmaa
        • コンタクト：
        • 主任研究者：
          • Tuomas Koskela, Professor
      • Sastamala、Pirkanmaa、フィンランド
        • Sastamala health and social services centre, The Wellbeing Services County of Pirkanmaa
        • コンタクト：
        • 主任研究者：
          • Tuomas Koskela, Professor
      • Tampere、Pirkanmaa、フィンランド
        • Hatanpää health and social services centre, The Wellbeing Services County of Pirkanmaa
        • コンタクト：
        • 主任研究者：
          • Tuomas Koskela, Professor
      • Tampere、Pirkanmaa、フィンランド
        • Hervanta health and social services centre, The Wellbeing Services County of Pirkanmaa
        • コンタクト：
        • 主任研究者：
          • Tuomas Koskela, Professor
      • Tampere、Pirkanmaa、フィンランド
        • Linnainmaa health and social services centre, The Wellbeing Services County of Pirkanmaa
        • コンタクト：
        • 主任研究者：
          • Tuomas Koskela, Professor
      • Valkeakoski、Pirkanmaa、フィンランド
        • Valkeakoski health and social services centre, The Wellbeing Services County of Pirkanmaa
        • コンタクト：
        • 主任研究者：
          • Tuomas Koskela, Professor

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
介入なし：Control
Usual Care for hypertension
実験的：Digital Care Pathway
Usual Care + Digital Care Pathway for 6 months
デバイス：Digital care pathway for hypertension
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.
実験的：Digital Care Pathway and Asynchronous Communication
Usual Care + Digital Care Pathway with Asynchronous Communication with nurse for 6 months
デバイス：Digital care pathway for hypertension
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.
デバイス：Asynchronous communication with nurse
Asynchronous communication means digital bidirectional non-real-time messaging between participant and nurse. It can be used with digital care pathway.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change from Baseline in the Office Systolic Blood Pressure Level at 6 Months
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change from Baseline in the Home Systolic Blood Pressure Level at 6 Months
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Wellbeing Services County of Pirkanmaa

協力者

Tampere University

捜査官

  • 主任研究者：Tuomas Koskela, Professor, Chief Physician、Faculty of Medicine and Health Technology, Tampere University, Finland. The Wellbeing Services County of Pirkanmaa, Finland

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月28日

一次修了 (推定)

2028年2月1日

研究の完了 (推定)

2028年8月1日

試験登録日

最初に提出

2026年8月25日

QC基準を満たした最初の提出物

2026年9月3日

最初の投稿 (実際)

2026年9月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月10日

QC基準を満たした最後の更新が送信されました

2026年9月3日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • R25071

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Individual participant data that underlie the results reported, after deidentification (text, tables, figures, and appendices).

IPD 共有時間枠

Beginning 3 months and ending 5 years after the publication of results.

IPD 共有アクセス基準

Upon reasonable request for researchers in the EU region.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL

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