Positive Psychology for Acute Coronary Syndrome Patients (PEACE-IV)
2020年5月6日 更新者：Jeff C. Huffman, MD、Massachusetts General Hospital
Positive Psychology for Acute Coronary Syndrome Patients: a Randomized, Controlled Pilot Trial
This is a randomized controlled pilot trial in approximately 50 acute coronary syndrome patients to determine if a 12 week, telephone-delivered, combined positive psychology-motivational interviewing intervention is feasible and more effective than a motivational interviewing health education program at improving health behaviors and other outcomes.
The investigators hypothesize that the intervention will be associated with better mental and physical health outcomes and better health behavior adherence compared to the motivational interviewing health education program.
調査の概要
詳細な説明
The initial study visit will occur in-person two weeks after discharge from the hospital.
Participants will meet with a member of the study staff (the study "trainer") and complete self-report questionnaires assessing health behavior adherence and mental and physical health.
Then, participants will be randomized to receive the positive psychology + motivational interviewing or the motivational interviewing health education interventions.
A study interventionist will provide a treatment manual specific to their condition, review the rationale for the initial exercise, and assign the first exercise.
If the participant is in the positive psychology + motivational interviewing condition, the trainer will explain the rationale for both the positive psychology and goal-setting portions of the program, and will be assigned the first exercise.
Similarly, if the participant is randomized into the motivational interviewing health education program, the interventionist will introduce them to the program and assign the first exercise.
Participants in both groups will then be given an accelerometer, which they will be asked to wear for 7 days to ensure that they are comfortable with the device and that useable data can be obtained from the participant.
Participants in both groups will then complete twelve 30-minute weekly phone sessions with a study trainer.
The phone sessions primarily will include a review of the prior week's session content and a discussion of the rationale and assignment of the next week's exercise/assignment.
Upon the completion of these calls, and again at a final follow-up timepoint at 24 weeks, a blinded member of the study staff will call participants to administer self-report outcome measures.
Participants will also be asked to wear an accelerometer at each of these follow-up timepoints as an objective measure of physical activity, which they will return by mail to the study staff.
研究の種類
介入
入学 (実際)
69
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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Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
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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
18年歳以上 (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:
- Adult patients admitted to Massachusetts General Hospital or Brigham and Women's Hospital inpatient units
- Diagnosis of acute coronary syndrome (using established criteria for myocardial infarction or unstable angina; confirmed via medical record and/or patient's treatment team)
- Age 18 or older
- Suboptimal adherence on MOS-SAS: Score < 15 OR Score = 15 with physical activity < 6
Exclusion Criteria:
- Cognitive deficits, assessed via a 6-item cognitive screen used to assess appropriate participation of medically ill patients in research studies.
- Medical conditions precluding interviews or likely to lead to death within 6 months, determined in consultation with the primary treatment team and cardiology co-investigator.
- Inability to perform moderate to vigorous physical activity, as defined by an inability to walk without aid of an assistive device such as a walker or cane, OR inability to walk at a steady pace for at least 5 minutes without stopping.
- Inability to communicate in English.
- Inability to participate in physical activity
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：ポジティブ心理学 + 動機付け面接
参加者は、毎週のポジティブ心理学の演習を完了し、身体活動に関連する目標を体系的に設定します。
スタディ トレーナーは、毎週電話でポジティブ心理学の演習を確認し、目標設定を容易にするために動機付け面接テクニックを使用します。
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介入のポジティブ心理学の部分については、スタディ トレーナーは、(a) 今週のポジティブ心理学の演習を確認し、(b) ポジティブ心理学マニュアルのガイド付きレビューを通じて、次の週のポジティブ心理学の演習の理論的根拠について話し合います。(c)来週のポジティブ心理学の演習を割り当てます。
動機付け面接の部分では、参加者は (a) 前週の身体活動の目標を確認し、(b) 身体活動を改善するためのテクニックについて話し合い、(c) 翌週の身体活動の目標を設定します。
スタディ トレーナーは、目標設定を促進するために、動機付けの面接テクニックを使用します。
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アクティブコンパレータ：Motivational Interviewing Health Education
Participants will speak on the telephone each week with a study trainer.
During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week.
Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
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Each week, participants will learn about a different health behavior topic related to cardiac health.
They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.
The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
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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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Feasibility of the PP-MI Based Health Behavior Intervention
時間枠：24 weeks
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Feasibility will be measured by examining the number of completed exercises.
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24 weeks
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Acceptability of the PP-MI Exercises: Utility Score
時間枠：Weeks 1-12
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Participants will provide ratings of utility after each exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful).
Weekly utility ratings were averaged to provide an overall utility score of the exercises.
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Weeks 1-12
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Acceptability of the PP-MI Exercises: Ease Score
時間枠：Weeks 1-12
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Participants will provide ratings of ease after each exercise, measured on a 10-point Likert scale (0=very difficult; 10=very easy).
Weekly ratings were averaged to provide an overall ease of the exercises.
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Weeks 1-12
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Minutes of Moderate to Vigorous Physical Activity (Actigraph)
時間枠：MVPA at 12 weeks and 24 weeks
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ActiGraph GT3X+ step counters are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness.
In this trial, participants will wear the accelerometer for one week at 12 weeks, and another week at 24 weeks to assess the feasibility of doing so and to ensure adequate capture of physical activity.
In our analysis, data on pre-ACS activity was collected using the International Physical Activity Questionnaire (IPAQ) to control for baseline activity.
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MVPA at 12 weeks and 24 weeks
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Change in Medication Adherence
時間枠：Change in score from Baseline to 12 weeks, 24 weeks
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Measured by Self-Reported Medication Adherence (SRMA), a two-item self-report medication adherence scale measuring percentage of time (in 10% increments) patients report taking their heart medications in the past one and two weeks.
Minimum: 0, Maximum:100.
Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks.
Higher score indicates greater levels of medication adherence.
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Change in score from Baseline to 12 weeks, 24 weeks
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Change in Dietary Adherence
時間枠：Change in score from Baseline to 12 weeks, 24 weeks
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Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat.
Minimum= 0; Maximum= 216.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate lower levels of dietary adherence.
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Change in score from Baseline to 12 weeks, 24 weeks
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Change in Positive Affect
時間枠：Change in score from Baseline to 12 weeks, 24 weeks
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The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect.
(Range: 10-50).
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate higher levels of positive affect.
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Change in score from Baseline to 12 weeks, 24 weeks
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Change in Trait Optimism
時間枠：Change in score from baseline to 12 week, 24 week
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Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism.
(Range: 0-24) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate higher levels of optimism.
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Change in score from baseline to 12 week, 24 week
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Change in State Optimism
時間枠：Change of score from Baseline to 12 weeks, 24 weeks
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Measured by the State Optimism Scale developed by our team (SOM), which aims to capture the changeable nature of optimism based on time and situation.
Minimum:7, Maximum:35.
The higher number indicates a greater level of optimism.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
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Change of score from Baseline to 12 weeks, 24 weeks
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Changes in HADS-A Scores
時間枠：Change in score from Baseline to 12 week, 24 week
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The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety.
This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients.
(Range: 0-21) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate higher levels of anxiety.
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Change in score from Baseline to 12 week, 24 week
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Change in HADS-D Scores
時間枠：Change in score from Baseline to 12 week, 24 week
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The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety.
This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients.(Range:
0-21).
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate worse outcome (i.e.
greater levels of depression).
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Change in score from Baseline to 12 week, 24 week
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Change in Physical Function
時間枠：Change of score from Baseline to 12 week, 24 week
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Measured by the Duke Activity Status Index (DASI), a 12-item questionnaire that inquires about activities of daily living, basic physical activity, and more strenuous physical function to gauge overall functional capacity.
Minimum: 0, Maximum: 58.2.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate greater levels of functional capacity.
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Change of score from Baseline to 12 week, 24 week
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Change in SF-12 Scores (Physical)
時間枠：Change of score from Baseline to 12 week, 24 week
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The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life.
This is an instrument which has been used in multiple cardiac studies in the past.
(SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each).
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate higher level of health related QoL.
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Change of score from Baseline to 12 week, 24 week
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Change in SF-12 Scores (Mental)
時間枠：Change of score from baseline to 12 and 24 weeks.
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The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life.
This is an instrument which has been used in multiple cardiac studies in the past.
(SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each).
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate higher level of health related QoL.
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Change of score from baseline to 12 and 24 weeks.
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Change in Adherence to Health Behaviors
時間枠：Change of score from Baseline to 12 week, 24 week
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Three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items assessing medication, diet, and exercise, will be measured individually and as a composite score.
(Range: 3-18) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate better adherence to health behaviors.
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Change of score from Baseline to 12 week, 24 week
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Change in Cardiac Symptoms
時間枠：Change of score from Baseline to 12 week, 24 week
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Measured by a checklist taken from the Women and Ischemia Syndrome Evaluation Study (WISE) to assess the presence and intensity of ten cardiac symptoms felt to best capture the range of symptoms experienced by ACS patients.
Minimum: 0, Maximum: 30.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate greater levels of cardiac symptoms.
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Change of score from Baseline to 12 week, 24 week
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Change in Physical Activity
時間枠：Change of score from Baseline to 12 week, 24 week
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Measured by the self-report International Physical Activity Questionnaire (IPAQ).
The measure asseses the types of intensity of physical activity that people do as part of their daily lives.
All activities are converted to multiples of resting energy expenditure (MET) minutes per week.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
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Change of score from Baseline to 12 week, 24 week
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Change in Perceived Stress
時間枠：Change of score from Baseline to 12 week, 24 week
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Measured by the Perceived Stress Scale (PSS-4) measure.
Minimum: 0, Maximum: 16.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks Higher scores indicate greater levels of stress.
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Change of score from Baseline to 12 week, 24 week
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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：Jeff Huffman, MD、Massachusetts General Hospital
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5月1日
一次修了 (実際)
2018年7月10日
研究の完了 (実際)
2018年11月26日
試験登録日
最初に提出
2017年4月6日
QC基準を満たした最初の提出物
2017年4月17日
最初の投稿 (実際)
2017年4月20日
学習記録の更新
投稿された最後の更新 (実際)
2020年5月14日
QC基準を満たした最後の更新が送信されました
2020年5月6日
最終確認日
2020年5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。