The Effect of Palliative Care Training on Symptom Management and Quality of Life in Chronic Heart Failure
2022年3月14日 更新者:Gülşah Çamcı、Marmara University
The Effect of Palliative Care Training on Symptom Management, Rehospitalization and Quality of Life in Chronic Heart Failure: : A Randomized Controlled Trial
Palliative care is of great importance because of poor quality of life and high mortality risk in advanced heart failure.
This study was planned as a randomized controlled trial to determine the effect of palliative care training on symptom management, rehospitalization, and quality of life among patients with heart failure.
調査の概要
詳細な説明
Patients were informed about the research and written informed consent was obtained.
Data were collected by face-to-face interviews within two days before discharge.
Patient information form and scales were applied to Patients in the intervention and control groups.
Patients in the intervention group were received education after filling the forms.
The training was given one by one at the hospital.
One or two relatives of patients were included in the training.
The patient was comfortably seated, and the room door was closed, face to face interaction was conducted.
The patient and his/her relatives were allowed to ask questions during the training.
The patient in the intervention group received at least 45 minutes of data collection from a case because of detailed training.
It took about 15 minutes to collect data from a patient in the control group.
In some patients, the training program was divided to be clearer.
The patients were traced by telephone at the first, third, and sixth months after discharge.
The investigator's phone number was presented to the patients and they were told that they could call at any time.
Continuous communication was ensured by giving the educator's phone number to the patients.
The training was repeated by contacting the phone.
The intervention group was retrained about symptoms they experienced during their telephone interview.
The training was given to the experimental group as planned.
No modifications/changes were made to the intervention during the study.
Special notes were taken for each patient.
The effect of the education given on the quality of life and symptom management was evaluated with questionnaires.
The intervention was adhered to as planned.
研究の種類
介入
入学 (実際)
84
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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Istanbul、七面鳥
- Marmara University
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Istanbul、七面鳥
- Marmara U.
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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~86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:
- 18-year-old or over,
- Class III and IV heart failure patients according to New York Heart Association (NYHA) classification,
- Patients without any communication problem to prevent participation in the research [loss of hearing, visual impairment, lack of understanding/speaking in Turkish], can be contacted by telephone, are literate.
- The patients who were diagnosed with heart failure at least six months ago accepted to participate voluntarily were also included in the study.
Exclusion Criteria:
- Patients who wish to quit their study voluntarily during the study period and patients who died or worsened during the study period.
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: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:palliative care education
The patients in the intervention group were presented palliative care training in addition to their usual care.
The training period lasts at least 45 minutes.
After the training, patients were given the book 'Palliative Care in Heart Failure'.
In this training, patients were informed about heart failure and pharmacological and non-pharmacological methods for symptoms such as dyspnea, pain, constipation, depression, edema, tiredness, nausea.
The patients were followed up by telephone at the first, third, and sixth months after discharge.
The patient's symptoms and quality of life were re-evaluated in telephone follow-up.
During the follow-up period, the patient's training related to symptoms was repeated.
The patients were referred to the physician for the symptoms and problems which they experienced in the house.
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The patients in the intervention group were presented palliative care training in addition to their usual care
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介入なし:usual care
Firstly, the usual care provided to patients was described.
It was determined that patients were not given regular and comprehensive training on heart failure, and no training was given on palliative care.
Written educational material was not given to the patients.
Patients were not followed up after discharge.
Palliative care was not discussed with patients and their relatives.
Also, they were not asked about their preferences.
In usual care, Heart failure patients received medical treatment for their symptoms during hospitalization.
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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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Edmonton symptom assessment scale
時間枠:six months
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ESAS consists of 10 symptoms as tiredness, pain, feeling of well-being, nausea, depression, anxiety, lack of appetite, drowsiness, shortness of breath, and others.
Each symptom is scored between 0 and 10.
While Zero points indicate no symptoms, 10 points are severe of symptoms.
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six months
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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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LVD-36-left ventricular dysfunction questionnaire
時間枠:six months
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The questionnaire consists of 36 questions and the questions are answered as true or false.
The correct answers are collected and indicated as the total percentage.
The score is 0-100.
High scores indicate poor quality of life.
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six months
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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。
スポンサー
捜査官
- 主任研究者:Gülşah Çamcı, PhD、Marmara University
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1月1日
一次修了 (実際)
2017年12月31日
研究の完了 (実際)
2018年11月10日
試験登録日
最初に提出
2022年3月4日
QC基準を満たした最初の提出物
2022年3月14日
最初の投稿 (実際)
2022年3月17日
学習記録の更新
投稿された最後の更新 (実際)
2022年3月17日
QC基準を満たした最後の更新が送信されました
2022年3月14日
最終確認日
2022年3月1日
詳しくは
本研究に関する用語
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
After the article is published, the results of the study will be shared.
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。