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Improving Outcomes After Traumatic Injury: A Goal Management Approach (GMT)

2017年4月21日 更新者:Kristin Archer、Vanderbilt University Medical Center

Improving Trauma Outcomes: A Goal Management Approach

The majority of trauma survivors experience prolonged and profound physical and psychosocial disability, with up to 50% unable to return to productive employment. The Centers for Disease Control (CDC) estimates that more than 1 million of these individuals experience a mild traumatic brain injury (TBI) and cost the United States nearly $17 billion each year. Symptoms related to mild TBI result in cognitive, functional, and emotional impairments that can lead to vocational and social disability. Long-term cognitive deficits include problems with memory and attention, and most importantly executive functioning. Depressive and post-traumatic stress disorder (PTSD) symptoms are extremely common in individuals with cognitive impairment, occurring in up to 50% and 33% of individuals, respectively. The investigators have found that 55% of trauma patients with mild TBI have profound cognitive impairments in executive functioning at one-year survival. Executive functioning is defined as "a cognitive domain that controls the execution of complex activities of daily living essential for purposeful, goal directed behaviors." Deficits in executive functioning are the most disabling of all cognitive impairments and affect a person's ability to manage effectively in one's personal and professional life. Current literature shows that deficits in executive functioning contribute to reduced quality of life, difficulty in returning to work, and persistent psychological distress in various medical and surgical populations. Cognitive rehabilitation has proven effective for decreasing persistent cognitive impairment and functional disability in patients with TBI. The overall goal of cognitive rehabilitation is not only to improve a person's ability to process and interpret information but to increase self-confidence and self-efficacy for coping with emotional distress. Despite evidence supporting the use of cognitive rehabilitation, few studies have systematically addressed cognitive treatment for individuals with mild TBI. Therefore, the investigators propose to conduct a three-group randomized controlled trial to determine the efficacy of Goal Management Training (GMT), a structured manual-based intervention targeting executive functions that impact a person's ability to carry out daily tasks. The investigators hypothesize that telephone-based GMT will improve cognitive functioning, functional status, and psychological health in trauma survivors with mild TBI. Emerging research suggests that telephone rehabilitation is a feasible and effective alternative (with much broader applicability) to clinic-based interventions. Trauma survivors with mild TBI have limited access to rehabilitation services due to financial constraints and mobility and geographic restrictions that render clinic-based rehabilitation impractical. This clinical trial will recruit 90 trauma survivors with mild TBI and cognitive deficits in executive functioning. Eligible participants will be randomized to either 10-week (1) telephone-based GMT; (2) telephone-based attention-control; or (3) usual care. Primary outcomes will include observed and self-reported executive functioning and self-reported functional status as measured by a battery of standardized and previously validated cognitive tests and instruments, including the Delis-Kaplan Executive Function System Tower Test, the Dysexecutive Questionnaire, and the Functional Activities Questionnaire. Secondary outcomes will consist of depressive and PTSD symptoms, as measured by the Patient Health Questionnaire-9 and PTSD Checklist - Civilian Version, respectively. Outcome data will be collected at baseline (6 weeks after hospitalization) and at 4 month (treatment completion) and 7 month follow-up from hospital discharge. Our cognitive rehabilitation intervention will serve to broadly disseminate evidenced-based cognitive strategies to a trauma population that has difficulty returning to productive life both inside and outside the home due to profound functional and psychological disability. Findings from this study will support future research to improve the cognitive, functional and psychological health of patients following major trauma through innovative rehabilitation interventions and delivery methods.

調査の概要

研究の種類

介入

入学 (実際)

91

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

    • Tennessee
      • Nashville、Tennessee、アメリカ、37232
        • Vanderbilt University Medical Center

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

21年~80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:

  1. Determination of mild TBI using American Congress of Rehabilitation Medicine guidelines;
  2. No history of schizophrenia, or other psychotic disorder or suicidal intent;
  3. English speaking due to feasibility of employing study personnel to deliver and assess the study intervention;
  4. Age 21 years or older;
  5. Able to provide a telephone number and a stable address; and
  6. Presence of cognitive deficits in executive functioning (defined as 1 SD below the norm referenced mean on any 2 of the following neuropsychological tests, the D-KEF Tower Test, Trails B, and FAS)

Exclusion Criteria:

  1. Having a CT scan showing an intracranial hemorrhage;
  2. Current alcohol or substance abuse dependence (within the last 6 months);
  3. Persons with neurological history other than TBI (e.g., premorbid epilepsy, multiple sclerosis, Alzheimer's disease);
  4. Pre-existing cognitive impairment as determined by a validated surrogate or patient questionnaire (defined as a score greater than 3.3 on the IQCODE instrument;
  5. History of pre-morbid learning disability;and
  6. Involvement in current litigation

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:ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的:Telephone-Based Goal Management Training
The GMT intervention targets cognitive deficits in executive functioning that impact a person's ability to carry out daily tasks. Participants learn how to recognize and stop absentmindedness and automatic pilot and how to reduce daily errors and 'slips' through goal setting. The telephone-based GMT condition includes 7 sessions delivered over the phone for 10 weeks.
他の名前:
  • GMT
アクティブコンパレータ:Telephone-Based Attention-Control
The attention group receives an educational intervention that is matched to the GMT intervention in terms of session length and contact with the study therapist. The telephone-based attention condition includes 7 sessions delivered over 10 weeks. Sessions address education on brain function and cognitive principles of memory, attention, language, perception, and motor skills. Education on stress reduction, sleep hygiene, energy management, exercise, communication, and nutrition are also provided
介入なし:Usual Care Control
Participants in the control group will receive usual care as determined by the treating surgeon. Usual care may include referral to a physical therapist, occupational therapist, psychiatrist, and/or psychologist and utilization of health services will be recorded during follow-up assessments.

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
D-KEFs Tower Test
時間枠:7 months after hospital discharge
cognitive test for executive functioning
7 months after hospital discharge
Trail Making Test B
時間枠:7 months after hospital discharge
Cognitive test for set shifting and cognitive flexibility
7 months after hospital discharge
Sustained Attention to Response Test
時間枠:7 months after hospital discharge
Cognitive test for failures of sustained attention
7 months after hospital discharge
FAS Verbal Fluency Test
時間枠:7 months after hospital discharge
Cognitive test for verbal fluency
7 months after hospital discharge

二次結果の測定

結果測定
メジャーの説明
時間枠
Dysexecutive Questionnaire
時間枠:7 months after hospital discharge
Self-reported executive functioning
7 months after hospital discharge
Functional Activities Questionnaire
時間枠:7 months after hospital discharge
Self-reported functional status
7 months after hospital discharge

その他の成果指標

結果測定
メジャーの説明
時間枠
Patient Health Questionnaire-9
時間枠:7 months after hospital discharge
Self-reported measure of depressive symptoms
7 months after hospital discharge
PTSD Checklist-Civilian Version (PCL-C)
時間枠:7 months after hospital discharge
Self-reported measure of PTSD symptoms
7 months after hospital discharge

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:Kristin Archer, PhD、Vanderbilt School of Medicine

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。

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

2013年1月1日

一次修了 (実際)

2016年9月1日

研究の完了 (実際)

2016年9月1日

試験登録日

最初に提出

2012年10月22日

QC基準を満たした最初の提出物

2012年10月23日

最初の投稿 (見積もり)

2012年10月26日

学習記録の更新

投稿された最後の更新 (実際)

2017年4月24日

QC基準を満たした最後の更新が送信されました

2017年4月21日

最終確認日

2017年4月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • 111484
  • H133G120052 (その他の助成金/資金番号:NIDRR)

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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