Medication Use and Quality of Life Among Older People (Pilot)
調査の概要
詳細な説明
In a pragmatic randomized controlled trial, this project will test whether a comprehensive and patient-centered deprescribing intervention can improve quality of life among older people with limited life expectancy. This registration concerns the initial pilot study. All patients included in the pilot study will receive the intervention (that is, the pilot study will not include randomization).
The intervention will comprise a series of consultations between the patient and general practitioner (GP) (at least three) to continuously adjust the patient's medication according to the patient's goals, needs, and preferences, thereby ensuring alignment with the patient's priorities. Thus, the purpose of this intervention is to initiate and facilitate a continued deprescribing process. The process can be summarized in seven steps: During an initial consultation (1: Consultation 0), the GP assesses patient eligibility. If the patient would like to participate, a project nurse subsequently visits the patient at home (2: Home visit) for retrieval of informed consent as well as baseline measurements. During the next consultation (3: Consultation 1), the patient and GP discuss how the patient feels about his/her medical treatment, and the GP provides the patient with written material for the patient to prepare prior to the next consultation. The patients prepares (4: Preparation) by considering and verbalizing his/her goals of care and treatment preferences. Simultaneously, a clinical pharmacist examines the patient's medication list and provides suggestions to the GP on which drugs can be continued and deprescribed, respectively. During the next consultation (5: Consultation 2), the patient and GP discuss the patient's preferences and initiate deprescribing initiatives aligned with the patient's priorities. During a new consultation (6: Consultation 3), the patient and GP follow up on the changes initiated and initiate new deprescribing initiatives if such can be identified. If needed, subsequent consultations (7: Consultation X) are planned until the patient and GP consider the patient's medical treatment optimal.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Region Of Southern Denmark
-
Odense、Region Of Southern Denmark、デンマーク、5000
- Odense University Hospital
-
-
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:
- Aged ≥80 years
- Take ≥8 different medications
- Have a life expectancy of <2 years, estimated via the Surprise Question ("Would you be surprised if this patient died within 1-2 years?") by the general practitioner
- Have a Mini-Mental State Exam (MMSE) score of ≥15
- Are able to provide informed consent
Exclusion Criteria:
- Not able to communicate
- Does not speak and understand Danish
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: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 |
|---|---|
|
他の:Consultations
The intervention will comprise a series of consultations between the patient and general practitioner (at least three), where the patient and general practitioner will continuously adjust the patient's medication according to the patient's goals, needs, and preferences.
|
The intervention will comprise a series of consultations between the patient and general practitioner (at least three), where the patient and general practitioner will continuously adjust the patient's medication according to the patient's goals, needs, and preferences.
|
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 |
|---|---|---|
|
HEALTH-RELATED QUALITY OF LIFE
時間枠:Baseline
|
Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
|
Baseline
|
|
CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE AT 3 MONTHS
時間枠:3 months
|
Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
|
3 months
|
|
CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE AT 6 MONTHS
時間枠:6 months
|
Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
|
6 months
|
|
HEALTH-RELATED QUALITY OF LIFE (DEPRESSION)
時間枠:Baseline
|
Health-related quality of life will be measured using the Danish version of the Depression List.
|
Baseline
|
|
CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 3 MONTHS
時間枠:3 months
|
Health-related quality of life will be measured using the Danish version of the Depression List.
|
3 months
|
|
CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 6 MONTHS
時間枠:6 months
|
Health-related quality of life will be measured using the Danish version of the Depression List.
|
6 months
|
|
MORTALITY
時間枠:3 months
|
Mortality will be assessed through the nationwide Danish Central Person Registry.
|
3 months
|
|
MORTALITY
時間枠:6 months
|
Mortality will be assessed through the nationwide Danish Central Person Registry.
|
6 months
|
|
MORTALITY
時間枠:12 months
|
Mortality will be assessed through the nationwide Danish Central Person Registry.
|
12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
機能レベル
時間枠:ベースライン、3 か月および 6 か月
|
機能レベルは、Vulnerable Elders Survey 13 (VES-13) のデンマーク語版を使用して測定されます。
|
ベースライン、3 か月および 6 か月
|
|
ハンドグリップの強さ
時間枠:ベースライン、3 か月および 6 か月
|
ハンドグリップダイナモメーターを使用してハンドグリップの強さを測定します。
|
ベースライン、3 か月および 6 か月
|
|
薬の変更回数
時間枠:3ヶ月、6ヶ月、12ヶ月
|
投薬変更の回数は、投薬リストを通じて評価されます。
|
3ヶ月、6ヶ月、12ヶ月
|
|
COGNITIVE FUNCTION
時間枠:Baseline, 3 months and 6 months
|
Cognitive function will be measured using the Danish version of the Mini-Mental State Examination-2 (MMSE-2) Standard Form.
|
Baseline, 3 months and 6 months
|
|
ABILITY TO SIT AND STAND
時間枠:Baseline, 3 months and 6 months
|
Ability to sit and stand will be measured via the 30-second stand-sit-test.
|
Baseline, 3 months and 6 months
|
|
NUMBER OF MEDICATIONS DISCONTINUED
時間枠:3 months, 6 months and 12 months
|
Number of medications dicontinued will be assessed through the medication lists.
|
3 months, 6 months and 12 months
|
|
HOSPITAL ADMISSIONS
時間枠:3 months, 6 months and 12 months
|
Admissions will be assessed through the nationwide Danish National Patient Register.
|
3 months, 6 months and 12 months
|
|
HEALTH CARE COSTS
時間枠:3 months, 6 months and 12 months
|
Health care costs.
|
3 months, 6 months and 12 months
|
|
SUCCESS RATE OF THE INTERVENTION
時間枠:3 months, 6 months and 12 months
|
Succes rate of the intervention.
|
3 months, 6 months and 12 months
|
協力者と研究者
捜査官
- 主任研究者:Anton Pottegård, Prof、apottegaard@health.sdu.dk
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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。