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Just-in-time Adaptive Feedback Systems to Assist Individuals With Spinal Cord Injury

2018年12月10日 更新者:Temple University
The objective of this study is to develop algorithms that incorporate each individual's automatically detected physical activity (PA) level and a clinician's PA level recommendation to provide a smartphone application that helps a person set safe and highly personalized PA goals. By adapting the goals in real-time based on the person's actual behavior, the system aims to keep the individual feeling positive and motivated towards a change in the PA behavior.

調査の概要

状態

完了

条件

詳細な説明

Lack of regular physical activity (PA) in the general population is a top public health concern, and this problem is even more acute among individuals with spinal cord injury (SCI). Research has shown that only a small percentage (<20%) of persons with SCI reported consistent PA. Individuals with SCI also experience secondary conditions such as pain, fatigue, weight gain, and deconditioning, conditions that are considered preventable through PA and exercise interventions.

The objective of this proposed study is to develop algorithms that incorporate each individual's PA level and a clinician's PA level recommendation to provide a mobile phone application that helps a person set PA goals that are safe, but also highly personalized. By adapting the goals in real-time based on the person's actual behavior, the system aims to keep the individual feeling positive and motivated.

Aim 1: Extend and utilize Physical Activity Monitor System (PAMS) to track PA levels, sedentary behavior, and secondary conditions such as pain, fatigue, and deconditioning in community settings.

Aim 2: Extend and utilize PAMS to passively monitor PA and provide continuous, but passive feedback about PA levels to individuals with SCI in community settings.

Aim 3: Extend and utilize PAMS to passively monitor PA and provide just-in-time persuasive and adaptive feedback to motivate individuals with SCI in community settings.

Sample size: A total of 20 individuals with SCI will take part in the study. The sample size for this pilot study is based on budget constraints and other pilot studies. This study will provide the pilot data required to compute the power for future studies.

Statistical Analysis: Univariate analysis will be performed to obtain a range of values and the central tendency for variables such as PA levels and sedentary behaviors. Sedentary behavior will be assessed by the time duration of non-movement of individuals with SCI and not just the total duration of being seated in their wheelchairs.

The investigators hypothesize that the PA level of individuals with SCI in community will be low compared to the PA level recommendations for individuals with disabilities in general. Furthermore, the sedentary behavior of individuals with SCI will be high compared to the general population.

Multiple regression analysis will be performed to assess a relationship between secondary conditions such as pain (scores), fatigue (scores), and deconditioning (reduced capacity scores) and PA levels. The investigators postulate that secondary conditions will be negatively correlated with the PA levels.

Repeated measures general linear model (GLM) analysis will be performed to assess the change in PA levels, sedentary behaviors and secondary conditions. In addition, linear mixed model analysis will be performed to develop a personal intercept (and maybe slope) for each participant compared to the mean intercept for each group. Mixed effects model analysis will provide correct estimates of intervention (passive feedback and just-in-time adaptive feedback) and other fixed effects (within-subjects factor) in the presence of correlated data (each participant at different time points) that arise from a data hierarchy (group). Non-parametric tests will be performed if the assumptions for parametric tests are not met.

研究の種類

介入

入学 (実際)

20

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

    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19122
        • Temple University

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~65年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • between 18-65 years of age
  • have been diagnosed with spinal cord injury
  • are at least 6 months post injury
  • use a manual wheelchair as their primary means of mobility (>80% of the time)
  • self-propel their wheelchair
  • are medically stable
  • have experience using a smartphone.

Exclusion Criteria:

  • have active pelvic or thigh wounds (pressure ulcers)
  • have a history of cardiovascular disease
  • are pregnant (self-report).

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:防止
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • 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
実験的:Passive feedback and JITAI

Passive feedback and JITAI

Second Phase - PA Level Feedback Third Phase - PA Level Feedback and Just-in-time Adaptive Intervention (JITAI)

Second Phase - PA Level Feedback

A PA recommendation handout based on PA guidelines for individuals with SCI will be provided. Participants continue to use the same sensing equipment as in phase one (baseline). The equipment consists of a smartwatch, a smartphone, and a wheel rotation monitor. Participants can view their feedback whenever they want, but will not be prompted with the information.

Third Phase - PA Level Feedback and Just-in-time Adaptive Intervention (JITAI)

The third phase of the study will be similar to the second phase of the study, but with an additional JITAI component. The JITAI component of the study will include providing proactively-prompted, real-time feedback through the smartphone and smartwatch when the participant performs a bout of moderate PA.

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 in Physical Activity level
時間枠:3 months
Energy expenditure in kilocalorie as measured by the physical activity monitor system for wheelchair users.
3 months
Change in Light-Intensity Physical Activity
時間枠:3 months
Minutes of light-intensity physical activity as measured by the physical activity monitor system for wheelchair users.
3 months
Change in Moderate and Vigorous-Intensity Physical Activity
時間枠:3 months
Minutes of moderate and vigorous-intensity physical activity as measured by the physical activity monitor system for wheelchair users.
3 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Light-intensity Leisure Time Physical Activity
時間枠:3 months
Minutes of light-intensity leisure time physical activity per week measured by self-report of Leisure Time Physical Activity Questionnaire for people with SCI.
3 months
Change in Moderate and Vigorous-intensity Leisure Time Physical Activity
時間枠:3 months
Minutes of moderate and vigorous-intensity leisure time physical activity per week measured by self-report of Leisure Time Physical Activity Questionnaire for people with SCI.
3 months
Change in Pain level for wheelchair users
時間枠:3 months
The pain level for wheelchair users is collected using the Wheelchair Users Shoulder Pain Index. The score ranges from a minimum pain level of 0 to a maximum pain level of 150.
3 months
Change in Pain level
時間枠:3 months
The general pain level was collected using the Chronic Pain Grade scale. The pain intensity score ranges from a minimum pain level of 0 to a maximum pain level of 100.
3 months
Change in Disability score due to Pain
時間枠:3 months
The general pain level was collected using the Chronic Pain Grade scale. Disability scores range from a minimum of 0 to a maximum of 100.
3 months
Change in Fatigue
時間枠:3 months
The fatigue is collected using the Fatigue Severity Scale (FSS). Fatigue scores range from a minimum of 0 to a maximum of 63.
3 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

捜査官

  • 主任研究者:Shivayogi V Hiremath, PhD、Temple University

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

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)

2017年7月31日

一次修了 (実際)

2018年11月21日

研究の完了 (実際)

2018年11月21日

試験登録日

最初に提出

2018年12月9日

QC基準を満たした最初の提出物

2018年12月10日

最初の投稿 (実際)

2018年12月12日

学習記録の更新

投稿された最後の更新 (実際)

2018年12月12日

QC基準を満たした最後の更新が送信されました

2018年12月10日

最終確認日

2018年12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

  • 23822 (その他の識別子:City of Hope Medical Center)

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?

いいえ

IPD プランの説明

The datasets generated during the current study are not publicly available as the authors do not have the permission to share participants' data.

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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