Partnership in Medication Management (PIMM) in Patients With Mood Disorders (PIMM)
Partnership in Medication Management (PIMM): The Effects of One-on-one Medication Training on Medication Adherence in Patients With Mood Disorders
調査の概要
詳細な説明
The efficacy of anti-depressants or lithium reported in clinical trials differs from clinical experience. Various factors such as non-adherence to treatment and poor tolerability to medications have been related to treatment non-response or treatment failure in mood disorders (major depressive disorder and bipolar disorder). Premature discontinuation of treatment for mood disorders is common. The long treatments, the patients' beliefs about medications, the lack of knowledge about the medication/treatment purpose, benefits, dosage, and side effects and the relationship between patient and healthcare providers affect treatment continuation.
Investigators are proposing a sequential explanatory mixed methods study to investigate a novel program for medication training in persons with mood disorders. The ultimate purpose of the program is to improve medication adherence in these persons. The primary component of the present study will be quantitative, i.e., a randomized controlled trial with 12 months of follow-up to examine the effect of one-on-one medication training, including the use of a checklist system, on medication adherence in patients with mood disorders. The training program will include education to improve patients' knowledge regarding their medication's purpose, dosage, benefits, and side effects. The program will also include tools like a checklist or alarm clock to remind patients of when and how to take their medication. Furthermore, the program will contain an interactive listening period where healthcare professionals involved in medication dispensing will listen to patients' concerns, questions and thoughts regarding their medications. To the best of the investigators' knowledge, no research has comprehensively examined whether one-on-one medication training, as described above, may improve medication adherence in patients with mood disorders.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Ontario
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Hamilton、Ontario、カナダ、L8N 4K7
- 募集
- Mood Disorders Program, St. Joseph's Healthcare Hamilton
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コンタクト：
- Carolina Oremus, MD,PhD(c)
- 電話番号：36326 +1(905) 522-1155
- メール：coremus@stjoes.ca
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コンタクト：
- Margaret C McKinnon, PhD,C.Psych.
- 電話番号：36645 +1(905) 522-1155
- メール：mmckinno@stjoes.ca
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- admitted to the inpatient clinic of the Mood Disorders Program, St. Joseph's Healthcare Hamilton
- with a primary diagnosis of bipolar disorder I or II, or major depressive disorder
- able to speak, read, and understand English.
Exclusion Criteria:
- cut off score on Montreal Cognitive Assessment (MOCA; clinical judgement)
- significant suicidal or homicidal risk
- a medical condition/treatment known to affect the brain
- acquired brain injury.
研究計画
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：ヘルスサービス研究
- 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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実験的：PIMM/SAM
Partnership in Medication Management (PIMM): The nurse and the attending physician will meet with the patient and ask how s/he administers medication at home (i.e., blister pack).
Initial education session: the nurse will teach the patient about his/her medications, dosage, purpose, when and how to take them.
Nurse and patient will establish reminders to take his/her medication.
Following the education session, patients will be required to notify the nurse when it is time to take their medications, where their medications are, dosage, purpose and side effects.
Self-Administered Medication (SAM): Patients will transition to SAM once the clinical team feels that no further medication changes are required.
SAM is also the model that the participants will follow after discharge.
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The PIMM program will include education to improve patients' knowledge regarding their medication's purpose, dosage, benefits, and side effects.
The program will also include tools like a checklist or alarm clock to remind patients of when and how to take their medication.
Furthermore, the program will contain an interactive listening period where healthcare professionals involved in medication dispensing will listen to patients' concerns, questions and thoughts regarding their medications.
他の名前：
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介入なし：Standard Prescribing Practice(SPP)
Standard prescribing practice (SPP): medication administration will proceed as standard practice.
Patients will not receive a personalized medication training.
The nurse will administer the patient's medications.
However, patients are encouraged to ask any questions regarding his/her medications.Patients will not be provided with any tool to help them to remember when to take their medications.
The nurse will record the patient's knowledge regarding his/her medications.
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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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Medication adherence measured by the Medication Adherence Rating Scale (MARS).
時間枠：Change from baseline in the Medication Adherence Rating Scale at 2 days before discharge and 1 week, 1 month, 3 months, 6 months and 12 months post-discharge
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Medication adherence measured by the Medication Adherence Rating Scale (MARS).
We will measure medication adherence at baseline and each follow up
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Change from baseline in the Medication Adherence Rating Scale at 2 days before discharge and 1 week, 1 month, 3 months, 6 months and 12 months post-discharge
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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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Time to re-hospitalization
時間枠：First time re-hospitalization any point during the 12-month follow-up period
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Investigators will compare the time to re-hospitalization between each study group.
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First time re-hospitalization any point during the 12-month follow-up period
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Costs of re-hospitalization
時間枠：First time re-hospitalization any point during the 12-month follow-up period
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Investigators will adopt a healthcare system perspective and compare the costs of first re-hospitalization between each study group.
When a participant is re-hospitalized for the first time at any point during the 12-month follow-up period, investigators will conduct a chart review of the entire re-hospitalization to identify all of the direct and indirect medical resources consumed during this re-hospitalization.
The chart review will cover the entire length of the re-hospitalization, even if this length exceeds the 12-month follow-up period for the participant in question.
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First time re-hospitalization any point during the 12-month follow-up period
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協力者と研究者
捜査官
- 主任研究者：Carolina Oremus, MD, PhD(c)、McMaster University
- 主任研究者：Sharon Simmons, RN,BScN,CPMHNc、St. Joseph's Healthcare Hamilton
- 主任研究者：Margaret C McKinnon, PhD,C.Psych.、McMaster University
出版物と役立つリンク
一般刊行物
- The World Health Organization.The global burden of disease: 2004 update, Table A2: Burden of disease in DALYs by cause, sex and income group in WHO regions, estimates for 2004. Geneva, Switzerland, 2008 (accessed on: March 6, 2014).
- Health Canada. A Report on Mental Illnesses in Canada. Ottawa: Health Canada, 2002.
- World Health Organization. Adherence to Long- Term Therapies: Evidence for Action. Geneva, Switzerland: World Health Organization, 2003.
- Rosa AR, Marco M, Fachel JM, Kapczinski F, Stein AT, Barros HM. Correlation between drug treatment adherence and lithium treatment attitudes and knowledge by bipolar patients. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Jan 30;31(1):217-24. doi: 10.1016/j.pnpbp.2006.08.007. Epub 2006 Sep 18.
- Nemeroff CB, Heim CM, Thase ME, Klein DN, Rush AJ, Schatzberg AF, Ninan PT, McCullough JP Jr, Weiss PM, Dunner DL, Rothbaum BO, Kornstein S, Keitner G, Keller MB. Differential responses to psychotherapy versus pharmacotherapy in patients with chronic forms of major depression and childhood trauma. Proc Natl Acad Sci U S A. 2003 Nov 25;100(24):14293-6. doi: 10.1073/pnas.2336126100. Epub 2003 Nov 13. Erratum In: Proc Natl Acad Sci U S A. 2005 Nov 8;102(45):16530.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
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。