Technology-based Intervention and Positive Psychological Training for Blood Pressure Control in African Americans (TechSupport)
2020年9月11日 更新者：Carolyn Still、Case Western Reserve University
The Effects of Technology-based Intervention and Positive Psychological Training on Cognitive Processing and Blood Pressure Control in African Americans
The purpose of this pilot study is to evaluate the effects of a theoretically-derived technology-based intervention (called TechSuPPorT) and its associated neurological mechanisms for hypertension self-management in African Americans.
The investigators will compare two intervention arms in this study, the Technology-Based Component Only arm (comparison group) and the TechSuPPorT arm (intervention group) in 20 African Americans with uncontrolled hypertension. We aim to:
- Determine whether there are differences in blood pressure (BP), health-related quality of life (HRQoL), and psychological health (affective well-being, depressive cognitions, anxiety) betweenTechSuPPorT and the Technology-based Component only arm.
- Determine whether there are differences in self-management behaviors (medication adherence, diet, exercise, self-monitoring BP) between the two groups.
- Examine whether self-efficacy, decision-making, motivation, patient activation, and perceived stress, and positive emotions mediate the relationship between the interventions and self-management behaviors.
- Determine if social support, demographics (age, gender, education), discrimination, and technology utilization moderate self-management behaviors, BP, HRQoL, and psychological health.
- Explore differences in neural processing (diffusion tensor imaging [DTI]/ task positive network [TPN] task-differentiation), and stress response (cortisol and inflammation panel) between the two groups.
調査の概要
詳細な説明
The investigators will conduct a two-arm randomized clinical trial to compare the effects of an Technology-Based Component Only arm and TechSuPPorT on self-management behaviors, BP control, and HRQoL outcomeson cognitive task switching between the DMN and TPN neural networks using Functional Magnetic Resonance Imaging (fMRI) and Diffusion Tensor Imaging (DTI).
Both groups will be exposed to the three Technology-based components: (a) six weekly web-based modules focused on improving African Americans' knowledge and skills of hypertension management; (b) personalized medication adherence support (SMS reminder messages, adherence feedback, health and lifestyle tips) through Medisafe, a smartphone app; and (c) self-monitor BP with study provided BP monitor.
Participants in the TechSuPPorT arm will receive the three Technology-based components plus positive psychological training, a structured online training and skill building techniques to promote optimism, resilience, well-being, and self-confidence.
研究の種類
介入
入学 (実際)
18
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。
研究場所
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Ohio
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Cleveland、Ohio、アメリカ、44143
- Case Western Reserve University
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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
25年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- self-identify as African American
- 25 years and older
- diagnosed with hypertension defined, as BP ≥ 130/80 mmHg
- Taking at least one antihypertensive medication(s)
- own an android smartphone
- able to read and understand English
Exclusion Criteria:
- are unable to give informed consent or judged to have impaired cognitive ability or severe memory deficits
- currently practicing positive psychological training
- have a history of medical conditions or procedures that is contraindicated for fMRI scanning (cardiac pacemaker, sternal wires, or metal implants)
- have a history of claustrophobia requiring anxiolytics or sedation
- pregnant at time of enrollment
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：支持療法
- 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 |
|---|---|
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プラセボコンパレーター：Technology-Based Component
A Technology-based interventions comprised of three technolgy components accessible via smartphone to support self-managing hypertension.
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This intervention is comprised of three technology components: a) six weekly web-based modules focused on improving knowledge and skills to manage hypertension; (b) personalized medication adherence support (SMS reminder messages, adherence feedback, health and lifestyle tips) through Medisafe app; and (c) self-monitoring blood pressure to support self-managing hypertension.
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実験的：TechSupport
A Technology-based interventions comprised of three technolgy components plus positive psychological training accessible by smartphone to support self-managing hypertension.
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The TechSupport intervention is the combination of both an behavioral and emotional intervention. Technology-based Components: This intervention is comprised of three technology components: a) six weekly web-based modules focused on improving knowledge and skills to manage hypertension; (b) personalized medication adherence support (SMS reminder messages, adherence feedback, health and lifestyle tips) through Medisafe app; and (c) self-monitoring blood pressure to support self-managing hypertension. Positive Psychological Training (PPT): This intervention will include a structured online training and skill building for PPT accessible by smartphone on techniques to promote optimism, resilience, well-being, and self-confidence. |
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 |
|---|---|---|
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Change in systolic and diastolic blood pressure
時間枠：Baseline to 8 weeks and 12 weeks
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Measure of participants' in clinic blood pressure (average of three blood pressure readings)
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Baseline to 8 weeks and 12 weeks
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PROMIS Global Health-10 [health-related quality of life]
時間枠：Baseline to 8 weeks and 12 weeks
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Change in total summed score on PROMIS Global Health-10.
Higher scores indicate greater health-related quality of life.
Range is 4-20.
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Baseline to 8 weeks and 12 weeks
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PROMIS Short Form, Positive Affect -15a [positive affect and well-being]
時間枠：Baseline to 8 weeks and 12 weeks
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Change in total summed score on PROMIS Short Form, Positive Affect 15a.
Higher scores indicate greater positive affect and well being.
Range is 15-45.
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Baseline to 8 weeks and 12 weeks
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PROMIS- 29, Depression Subscale 4a [depressive symptoms]
時間枠：Baseline to 8 weeks and 12 weeks
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Change in total summed PROMIS-29, Depression Subscale 4a.
Higher scores indicate greater depressive symptoms.
Range is 4 to 20.
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Baseline to 8 weeks and 12 weeks
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PROMIS- 29, Anxiety Subscale 4a [anxiety symptoms]
時間枠：Baseline to 8 weeks and 12 weeks
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Change in total summed PROMIS-29, Anxiety subscale.
Higher scores indicate greater anxiety.
Range is 4-20.
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Baseline to 8 weeks and 12 weeks
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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。
捜査官
- 主任研究者：Carolyn H Still, PhD、University Hospitals Cleveland Medical Center
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
- Still CH, Jack AI, Wright KD, Sattar A, Moore SM. Neural Processing of Health Information and Hypertension Self-Management in African Americans. Nurs Res. 2022 Jul-Aug 01;71(4):303-312. doi: 10.1097/NNR.0000000000000592. Epub 2022 Mar 18.
- Still CH, Margevicius S, Harwell C, Huang MC, Martin L, Dang PB, Wright Jnr JT. A Community and Technology-Based Approach for Hypertension Self-Management (COACHMAN) to Improve Blood Pressure Control in African Americans: Results from a Pilot Study. Patient Prefer Adherence. 2020 Nov 23;14:2301-2313. doi: 10.2147/PPA.S283086. eCollection 2020.
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)
2018年10月25日
一次修了 (実際)
2019年7月31日
研究の完了 (実際)
2019年7月31日
試験登録日
最初に提出
2018年10月25日
QC基準を満たした最初の提出物
2018年10月25日
最初の投稿 (実際)
2018年10月29日
学習記録の更新
投稿された最後の更新 (実際)
2020年9月16日
QC基準を満たした最後の更新が送信されました
2020年9月11日
最終確認日
2020年9月1日
詳しくは
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。