Evaluating the Efficacy of a Detection and Prevention Program for Frail Community-dwelling Older Adults (D-SCOPE)
2019年4月24日 更新者：Liesbeth De Donder、Vrije Universiteit Brussel
Study Protocol of the D-SCOPE Project With a Randomized Controlled Trial, Evaluating the Efficacy of a Detection and Prevention Program for Frail Community-dwelling Older Adults
The evaluation of a detection and prevention program which aims to create a continuum of care and support for frail community-dwelling older people (from early detection, over intervention, to follow-up).
First, the program aims to develop methods to easily, accurately and timely detect and prevent a negative frailty-balance in older people.
Second, the study aims to improve the quality and efficacy of care and support given to frail community-dwelling older people.
調査の概要
研究の種類
介入
入学 (実際)
869
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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Gent、ベルギー、9000
- OCMW Gent
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Knokke-Heist、ベルギー、8300
- OCMW Knokke-Heist
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Tienen、ベルギー、3300
- OCMW Tienen
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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
60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:
Sample 1: 150 older people per municipality (total: 3 municipalities) (inclusion criteria: at least one selection criterion)
- Gender: 75 men - 75 women
- Age: 25 older people aged between 60 and 70 years old - 125 older people older than 70 years
- Marital status: 50 older people with partner - 100 older people without partner
- Living situation: 100 older people who have not moved last 10 years - 50 older people who have moved last 10 years
- Migration background: 100 older people born in Belgium - 50 older people born elsewhere
Sample 2: 150 older people per municipality (total: 3 municipalities) (inclusion criteria: all selection criteria at once)
- 75 men, older than 70 years, living together/widowed/divorced/never married, moved last 10 years
- 75 women, older than 70 years, widowed/divorced/never married, moved last 10 years
Exclusion Criteria:
- Current institutionalization
- Current hospitalization
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：4倍
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：Risk of being frail experimental group
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Offering tailored care and support whereby the competences, strengths and resources of the older person are taken into account.The intervention will be an enhancement of usual care and will depend on the availability of the municipality, and could be formal (i.e., home care) or informal (e.g.
activities of an older adult's association).
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介入なし：Risk of being frail control group
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介入なし：No/low risk of being frail
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介入なし：Risk of being frail care avoiders
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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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Change from baseline Quality of Life at 6 months
時間枠：Assessed during baseline testing + 6 months after inclusion
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One question from the WHOQOL-BREF will be used to measure the quality of life of participants (1 item).
Older participants will also be asked to rate their quality of life on a scale from 0 to 10.
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Assessed during baseline testing + 6 months after inclusion
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Change from baseline Satisfaction with Life at 6 months
時間枠：Assessed during baseline testing + 6 months after inclusion
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The Satisfaction with Life Scale will be administered to explore the life satisfaction of the participants (5 items)
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Assessed during baseline testing + 6 months after inclusion
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Change from baseline sense of mastery at 6 months
時間枠：Assessed during baseline testing + 6 months after inclusion
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To assess the sense of mastery of older people, the current mastery questionnaire will be used and one self-constructed item will be added which will assess mastery in relation to others.
Older participants will also be asked to rate their mastery on a scale from 0 to 10.
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Assessed during baseline testing + 6 months after inclusion
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Change from baseline Meaning in Life at 6 months
時間枠：Assessed during baseline testing + 6 months after inclusion
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Meaning in life will be evaluated with 5 items from the Meaning in Life Questionnaire (MLQ).
Older participants will also be asked to rate their meaning in life on a scale from 0 to 10.
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Assessed during baseline testing + 6 months after inclusion
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Change from baseline Community Inclusion at 6 months
時間枠：Assessed during baseline testing + 6 months after inclusion
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Community inclusion will be measured using 1 item from the Community Integration Measure (CIM).
Older participants will also be asked to rate their community inclusion on a scale from 0 to 10.
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Assessed during baseline testing + 6 months after inclusion
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Change from baseline aging well in place at 6 months
時間枠：Assessed during baseline testing + 6 months after inclusion
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One self-constructed question (1 item) will assess if the older person lives at home in a qualitative manner
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Assessed during baseline testing + 6 months after inclusion
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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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Multidimensional frailty
時間枠：Assessed during baseline testing + 6 months after inclusion
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The Comprehensive Frailty Assessment Instrument (CFAI) will be used to measure multidimensional frailty: physical, cognitive, psychological, social and environmental frailty
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Assessed during baseline testing + 6 months after inclusion
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Physical phenotype of frailty
時間枠：Assessed during baseline testing + 6 months after inclusion
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The Fried's phenotype of frailty will be used to assess the physical phenotype of frailty as well as the questionnaire of Op het Veld
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Assessed during baseline testing + 6 months after inclusion
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Feeling frail
時間枠：Assessed during baseline testing + 6 months after inclusion
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The subjective feeling of frailty will be assessed using 1 self-constructed question and will assess to what extent an older person feels frail
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Assessed during baseline testing + 6 months after inclusion
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Resilience
時間枠：Assessed during baseline testing + 6 months after inclusion
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Resilience will be measured using the Connor-Davidson Resilience Scale (CD-RISC2), which is an abbreviated 2-item version of the original scale
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Assessed during baseline testing + 6 months after inclusion
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Coping
時間枠：Assessed during baseline testing + 6 months after inclusion
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Coping will be measured using 12 items from the BRIEF cope.
Two items from active coping, positive reframing, religion, use of emotional support and self-distraction and one item from acceptance and behavioral disengagement will be used
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Assessed during baseline testing + 6 months after inclusion
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Help needed for activities in daily life
時間枠：Assessed during baseline testing + 6 months after inclusion
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Older people will be asked if they need help with 8 activities of daily life, and to what extent the help they receive for these activities is sufficient.
These questions are adapted from the questionnaire of the Belgian Ageing Studies (BAS)
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Assessed during baseline testing + 6 months after inclusion
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Informal and formal care
時間枠：Assessed during baseline testing + 6 months after inclusion
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Older people will be asked if they receive care from 6 informal and 14 formal caregivers and if they are satisfied with the help they receive from these caregivers.
These questions are adapted from the BAS-questionnaire.
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Assessed during baseline testing + 6 months after inclusion
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Medical care
時間枠：Assessed during baseline testing + 6 months after inclusion
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The participants will be asked if they needed to go to the hospital, to a residential setting and a rehabilitation center over the past 6 months (day case/overnight stay).
These questions are adapted from the Health Interview Survey.
In addition, the participants will be asked when they visited the general practitioner for the last time over the last 6 months.
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Assessed during baseline testing + 6 months after inclusion
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Leisure time
時間枠：Assessed during baseline testing + 6 months after inclusion
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Leisure time will be measured by using an adapted question with 8 items derived from the BAS-questionnaire and will examine how often the participants perform the listed activities
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Assessed during baseline testing + 6 months after inclusion
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Neighborhood
時間枠：Assessed during baseline testing + 6 months after inclusion
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Different dimensions of neighborhood will be assessed.
First, the social environment will be administered by using 3 items from the social cohesion dimension of the Neighbourhood Scale.
Second, the physical environment will be explored by using 4 items from the BAS-questionnaire as well as from the Neighbourhood Environment Walkability Scale.
Finally, low-key participation will be examined by using 2 items from the questionnaire of Oswald & Konopik.
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Assessed during baseline testing + 6 months after inclusion
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Life-events
時間枠：Assessed during baseline testing + 6 months after inclusion
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A shortened version of the Geriatric Adverse Life Events Scale (GALES) will be adapted to assess to occurrence of life-events (11 items)
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Assessed during baseline testing + 6 months after inclusion
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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。
協力者
捜査官
- 主任研究者：Liesbeth De Donder, Prof. Dr.、Vrije Universiteit Brussel
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 (実際)
2017年6月1日
一次修了 (実際)
2018年4月30日
研究の完了 (実際)
2018年6月30日
試験登録日
最初に提出
2017年5月17日
QC基準を満たした最初の提出物
2017年5月23日
最初の投稿 (実際)
2017年5月30日
学習記録の更新
投稿された最後の更新 (実際)
2019年4月25日
QC基準を満たした最後の更新が送信されました
2019年4月24日
最終確認日
2019年4月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- D-SCOPE IWT 140027
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。
Tailored care and supportの臨床試験
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University of HawaiiNational Institute on Minority Health and Health Disparities (NIMHD)完了
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Kaiser PermanenteNational Institute of Mental Health (NIMH); University of Washington招待による登録
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Chang Gung University of Science and Technologyまだ募集していません
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University of BirminghamNational Institute for Health Research, United Kingdomわからない
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Massachusetts General HospitalPatient-Centered Outcomes Research Institute; Dartmouth-Hitchcock Medical Center; Griffin Hospital と他の協力者募集