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コミュニティ設定でNeoSpotを使用する可能性

出産前ケアコミュニティアウトリーチ中のコミュニティヘルスワーカーによるバイタルサイン評価の実現可能性

Continuous vital sign monitoring is a basic tenet of specialized care in the developed world that is vastly underutilized during hospital or clinic admissions or outpatient routine visits in most low-and-middle income countries (LMICs). Despite the positive outcomes associated with vital sign monitoring (i.e., increased survival-to-discharge rates, lower complication rates and shorter length of stay in hospital), the prohibitive costs of conventional patient monitors and the difficulty in maintaining complex medical equipment limit its practice in the developing world.

Currently, due to lack of medical supplies, most ANC clinics - within the health facilities or during outreach activities - do not monitor for vital signs and blood pressure among pregnant women. While many devices exist, their ease of use and high-cost, including maintenance costs, hinder screening and monitoring programs in low resource settings. Accurate and low-cost vital sign monitoring devices are required to improve identification and treatment of women with danger signs during their routine ANC visits. To meet the growing demand for vital sign monitors during the COVID-19 pandemic, Neopenda has adapted an affordable, wearable, wireless vital sign monitoring solution (neoSpotTM), that measures temperature, respiration rate, blood oxygen saturation, pulse rate, and blood pressure.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

Continuous vital sign monitoring is a basic tenet of specialized care in the developed world that is vastly underutilized during hospital or clinic admissions or outpatient routine visits in most low-and-middle income countries (LMICs). Despite the positive outcomes associated with vital sign monitoring (i.e., increased survival-to-discharge rates, lower complication rates and shorter length of stay in hospital),1 the prohibitive costs of conventional patient monitors and the difficulty in maintaining complex medical equipment limit its practice in the developing world.

Wearable health devices (WHDs) are increasingly helping people better monitor their health status both at an activity/fitness level for self-health tracking and at a medical level providing more data to healthcare providers to increase the potential for early diagnosis and guidance of treatment. Key advancements in technology are enabling the creation of smaller computers than ever before; allowing wearable technology to incorporate miniaturized systems to enhance the quality and convenience of patient care.1 Advances in materials science, chemical analysis techniques, equipment design and manufacturing methods have further laid the foundation for the continuous evolution of wearable systems over the years.2

WHDs when properly designed, implemented and adopted can provide ample benefits for healthcare providers and patients. Wearable technologies like Apple watch, Fitbit, Jawbone, ViSi Mobile and Vital Connect wireless patch have been used in tracking personal physiological and biological parameters for routine activity performance and/or clinical monitoring.3,4 These devices collect data such as heart rate, stress levels, obesity, oxygen saturation, blood pressure and calories; and serve a broad range of use cases from newborn to elderly patients in different settings such as hospitals, nursing homes and homecare settings.

Measurement of vital signs in both in- and out-patient departments and during community outreach activities is necessary to assess the clinical situation of the patient and capture early warning scores for deterioration. The currently practice in most LMICs is for a clinician to take routine vital sign measurements intermittently and manually record these on a clinical chart. However, this leaves a lot of room for missed detection of early warning scores. Delays in diagnosing clinical deterioration prevent clinicians from taking corrective actions and are associated with increased complication rates and mortality. The use of wearable devices for long term monitoring is intended to provide instant diagnosis of acute events that will in turn lead to more effective and timely treatment of patients.5 Furthermore, the situation becomes more dire during community outreach activities (i.e., child health week, community ANC outreach, etc.), which are usually conducted by limited clinicians and several community health workers (CHWs).

In contrast to the traditional monitoring devices that have been in use in clinical settings, WHDs may be more suited to the constraints of low-resources settings. Conventional medical equipment frequently fail in health facilities in LMICs due to complex design and specifications, and environmental constraints including power instability, internet access, space limitations and availability of spare parts. This calls upon the need for more feasible innovations to improve on the quality of care for people living in LMICs. WHDs offer a promising solution.

Currently, due to lack of medical supplies, most ANC clinics - within the health facilities or during outreach activities - do not monitor for vital signs and blood pressure among pregnant women. While many devices exist, their ease of use and high-cost, including maintenance costs, hinder screening and monitoring programs in low resource settings. Accurate and low-cost vital sign monitoring devices are required to improve identification and treatment of women with danger signs during their routine ANC visits. To meet the growing demand for vital sign monitors during the COVID-19 pandemic, Neopenda has adapted an affordable, wearable, wireless vital sign monitoring solution (neoSpotTM), that measures temperature, respiration rate, blood oxygen saturation, pulse rate, and blood pressure.

研究の種類

観察的

入学 (実際)

149

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。

研究場所

    • Lusaka Province
      • Lusaka、Lusaka Province、ザンビア、10101
        • Kanyama First Level Hospital

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

18年~45年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

女性

サンプリング方法

非確率サンプル

調査対象母集団

Pregnant women residing at Kanyama compound and attending ANC care during routine community outreach activities will be approached, screened, and consented for study participation.

Community Health Workers who have used the device on enrolled study participants (pregnant women) will under-go in-depth interviews.

説明

Pregnant women:

Inclusion criteria

  1. Pregnant
  2. 18+ years of age
  3. Willing to consent

Exclusion criteria

  1. Unable to consent
  2. Not pregnant
  3. Age below 18 years

In-depth Interviews:

  1. Community Health Workers who have used the NeoSpot device
  2. Pregnant women who have experienced the device and enrolled in the study

2. 18+ years of age 3. Willing to consent

Exclusion criteria

  1. Pregnant women not enrolled in the study
  2. Unable to consent

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

  • 観測モデル:CASE_ONLY
  • 時間の展望:CROSS_SECTIONAL

コホートと介入

グループ/コホート
介入・治療
Pregnant women

Pregnant women attending antenatal care clinic during routine community outreach activities in Lusaka, Zambia.

Pregnant women will undergo screening of their vital signs using the NeoSpot device.

他の名前:
  • バイタルサイン測定

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
Feasibility of using a wearable, wireless vital sign monitoring solution NeoSpot device by Community Health Workers (CHWs)
時間枠:Baseline to day 1

To describe the feasibility of CHWs to use the NeoSpot device during community ANC outreach through in-depth interviews

Baseline to day 1
Acceptability of using a wearable, wireless vital sign monitoring solution NeoSpot device by Community Health Workers (CHWs)
時間枠:Baseline to day 1

To describe the acceptability of CHWs to use the NeoSpot device during community ANC outreach through in-depth interviews

Baseline to day 1

二次結果の測定

結果測定
メジャーの説明
時間枠
Acceptability of using a wearable, wireless vital sign monitoring solution NeoSpot device by pregnant women
時間枠:Baseline to day 1

To describe the acceptability of pregnant women to be screened using the NeoSpot device during community ANC outreach through in-depth interviews

Baseline to day 1
Collect photoplethysmograph (PPG) data using a wearable, wireless vital sign monitoring solution NeoSpot device
時間枠:Baseline to day 1

To obtain raw PPG data from the prototype NeoSpot device which will be used in the development of an accurate and reliable blood pressure algorithm.

Baseline to day 1

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。

協力者

捜査官

  • 主任研究者:Albert Manasyan, MD、Center for Infectious Disease Research in Zambia (CIDRZ)

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 (実際)

2023年1月15日

一次修了 (実際)

2024年4月30日

研究の完了 (実際)

2024年4月30日

試験登録日

最初に提出

2022年9月13日

QC基準を満たした最初の提出物

2022年12月14日

最初の投稿 (実際)

2022年12月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月25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22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

その他の研究ID番号

  • NeoSpot 3109-2022

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

De-identified study data will be available to other researchers upon reasonable request to the study PI.

IPD 共有時間枠

Following study closure and publication of the main study findings.

IPD 共有アクセス基準

De-identified study data will be available to other researchers upon reasonable request to the study PI.

IPD 共有サポート情報タイプ

  • SAP
  • ICF
  • ANALYTIC_CODE

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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