The WARM Study is a Pilot Study That Aims to Investigate the Impact of Environmental Factors on Acute and Chronic Wounds, Mental Illness, and Social Factors Among People Experiencing Housing Emergencies in Augsburg. (WARM)
Impact of Environmental Factors on Acute and Chronic Wounds, Mental Illness, and Social Factors Among People Experiencing Housing Emergencies in Augsburg
Providing healthcare to homeless people is a key and challenging task, both for society as a whole and for medical and psychosocial professionals. It must be noted that the standard healthcare system is hardly used, or can only be used to an insufficient extent, by homeless people, and therefore does not comprehensively reach this group. One low-threshold and acceptance-oriented service outside the standard care system is the Johanniter-Hilfsmobil, which was established on June 3, 2024, as an innovative approach to healthcare for homeless people in Augsburg and will be scientifically examined in the following study.
The aim is to compare acute and chronic wounds in people experiencing housing emergencies who are treated by the Johanniter-Hilfsmobil with those of patients who attend the outpatient wound clinic at the Clinic for Vascular Surgery at Augsburg University Hospital.
In addition, a saliva test will be carried out to estimate the amount and type of substance consumed, and a survey will be conducted among drug-dependent test subjects who present themselves either via the Johanniter-Hilfsmobil or via the substitution outpatient clinic of the Clinic for Psychiatry, Psychotherapy, and Psychosomatics at Augsburg District Hospital.
Another focus of research is the quantitative and qualitative analysis of the psychosocial living situation and environmental influences on users of the Johanniter-Hilfsmobil.
調査の概要
状態
詳細な説明
The primary endpoint is to identify positive and negative influences of environmental factors on the development, progression, and healing of somatic and psychiatric illnesses in homeless people in Augsburg. The answers to the resulting research questions listed below should contribute to the development of a sustainable diagnosis and therapy system by the Johanniter-Hilfsmobil for people in housing emergencies without access to the regular health care system in Augsburg, optimizing addiction treatment for homeless people in the region, and establishing a prevention program for people experiencing housing emergencies in Augsburg, thereby positively influencing the environmental factors described. The long-term plan is to set up a wound and vascular consultation service for people experiencing housing emergencies to improve medical treatment and reintegration into the regular healthcare system.
A comparison will be made between acute and chronic wounds in people experiencing housing emergencies who are treated by the Johanniter mobile emergency service and those of patients who attend outpatient wound consultations at the Clinic for Vascular Surgery at Augsburg University Hospital. The following data will be collected: wound area and volume, as well as qualitative and quantitative analysis of bacterial and/or fungal colonization by taking swabs from the wound bed and performing corresponding laboratory chemical analysis. In addition, the cause or origin of the wounds, the type of diagnostics performed, and causal therapeutic measures taken to date, as well as the number and regularity of check-ups performed, will be recorded. Furthermore, the influence of environmental factors (including temperature, light, radiation), comorbidities, and nutritional status on wound healing and the effects of dressing sets provided as part of the study on the healing process of the wounds will be analyzed. Data collection will be carried out on an outpatient basis during treatment in the Johanniter-Hilfsmobil. In addition, the existing cardiovascular risk factors will be assessed and a vascular step-by-step diagnosis will be performed, including pulse status assessment and, in the event of pathological findings, non-invasive vascular imaging using ankle-brachial index determination and color-coded duplex sonography (FKDS).
In addition, semi-quantitative and quantitative saliva tests and a questionnaire survey are conducted among drug-dependent subjects who present themselves either via the Johanniter-Hilfsmobil or via the substitution outpatient clinic of the Clinic for Psychiatry, Psychotherapy, and Psychosomatics at Augsburg District Hospital.
Another focus of research is the quantitative analysis of the psychosocial living situation due to exceptional environmental influences based on subjective and/or objective recording of the following constructs and categories among users of the Johanniter-Hilfsmobil using a standardized questionnaire: Life situation index (material situation, gainful employment, housing, health, safety, participation/social networks), environmental influences and weather conditions (heat/cold, precipitation, wind, air quality, noise, garbage/unhygienic conditions), opportunities for a healthy lifestyle (nutrition, access to drinking water, sleep, regeneration), use of public space and urban infrastructure (mobility, participation, defensive architecture), experiences of loneliness, and experiences with and access to the medical and psychosocial care system. The questionnaire integrates the following measurement instruments/scales, among others: "Life Situation Index for Homeless People", "RTLS - Rasch-Type Loneliness Scale".
However, since this is a very specific target group that has been largely neglected in scientific analysis, the questionnaire also requires some self-formulated items that are appropriate for the research project.
In a final step, a qualitative analysis will be conducted through guided interviews with users of the Johanniter-Hilfsmobil to gain a deeper understanding of the quantitative findings on the psychosocial living situation and the environmental influences to which they are exposed.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Bavaria
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Augsburg、Bavaria、ドイツ、86156
- University Hospital Augsburg
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コンタクト：
- Tobias D Warm, Dr. med.
- 電話番号：+498214002655
- メール：tobias.warm@uk-augsburg.de
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コンタクト：
- Alexander Hyhlik-Dürr, Prof. Dr. med.
- 電話番号：+498214002655
- メール：alexander.hyhlik-duerr@uk-augsburg.de
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age over 18
- Existing capacity to consent to participation in the study, which will be verified and documented by the study physicians
- Inclusion of patients who present for wound treatment at the Johanniter-Hilfsmobil, the wound consultation hour of the Clinic for Vascular Surgery at Augsburg University Hospital and/or the substitution outpatient clinic of the Clinic for Psychiatry, Psychotherapy and Psychosomatics at Augsburg District Hospital
- Written consent to participate in the study has been obtained from the test subject.
Exclusion Criteria:
- Minderjährigkeit
- Fehlende schriftliche Einwilligung zur Studienteilnahme
- Instabiler somatischer Zustand der Betroffenen
- Akute Selbst- und Fremdgefährdung
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：基礎科学
- 割り当て：非ランダム化
- 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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介入なし：Saliva testing
Semi-quantitative and quantitative saliva tests and a questionnaire survey are conducted on drug-dependent subjects who present themselves either via the Johanniter-Hilfsmobil or via the substitution outpatient clinic of the Clinic for Psychiatry, Psychotherapy and Psychosomatics at Augsburg District Hospital.
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実験的：Wound Care Treatment
A comparison will be made between acute and chronic wounds in people experiencing housing emergencies who are treated by the Johanniter mobile emergency service and those in patients who attend outpatient wound consultations at the Clinic for Vascular Surgery at Augsburg University Hospital. The following data will be collected: wound area and volume, as well as qualitative and quantitative analysis of bacterial and/or fungal colonisation by taking swabs from the wound bed and performing the corresponding laboratory chemical analysis. Furthermore, the cause or origin of the wounds, the type of diagnostics performed and causal therapeutic measures taken to date, as well as the number and regularity of the checks carried out will be recorded. |
A comparison will be made between acute and chronic wounds in people experiencing housing emergencies who are treated by the Johanniter mobile emergency service and those of patients who attend outpatient wound consultations at the Clinic for Vascular Surgery at Augsburg University Hospital. The following data will be collected: wound area and volume, as well as qualitative and quantitative analysis of bacterial and/or fungal colonisation by taking swabs from the wound bed and performing the corresponding laboratory chemical analysis. In addition, the cause or origin of the wounds, the type of diagnostics performed and causal therapeutic measures taken to date, as well as the number and regularity of the checks carried out will be recorded. The influence of environmental factors, comorbidities and nutritional status on wound healing and the effects of the dressing sets provided as part of the study on the healing process of the wounds will also be analysed. |
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介入なし：Questionnaire on psychosocial life situation
The quantitative analysis of the psychosocial living situation due to exceptional environmental influences based on subjective and/or objective recording of the following constructs and categories among users of the Johanniter-Hilfsmobil using a standardised questionnaire: Life situation index (material situation, gainful employment, housing, health, safety, participation/social networks), environmental influences and weather conditions (heat/cold, precipitation, wind, air quality, noise, rubbish/unhygienic conditions), opportunities for a healthy lifestyle (nutrition, access to drinking water, sleep, regeneration), use of public space and urban infrastructure (mobility, participation, defensive architecture), experiences of loneliness, and experiences with and access to the medical and psychosocial care system.
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介入なし：Guided interview on psychosocial circumstances
A qualitative analysis will be conducted through guided interviews with up to 15 users of the Johanniter-Hilfsmobil to gain a deeper understanding of the quantitative findings on the psychosocial living situation and the environmental influences to which they are exposed.
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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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Identification of the positive and negative effects of environmental factors on the onset, progression and recovery from of chronic wounds among homeless people who use the Johanniter-Hilfsmobil in Augsburg
時間枠：0-365 days
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To answer the research question, the following data will be collected from study participants via a questionnaire and clinical examination:
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0-365 days
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Identification of a discrepancy between the substance subjectively perceived to have been consumed and the substance objectively detectable in drug-dependent homeless individuals
時間枠：0 - 365 days
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In order to identify any discrepancies between the substance the study participant subjectively believes they have consumed and the substance objectively detected, saliva tests are carried out which are chemically analysed in the laboratory for the presence of the following groups of substances:
To determine the substance the participant subjectively perceives to have consumed, a questionnaire is administered to assess the participant's current substance use. |
0 - 365 days
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Assessing the impact of environmental factors on the psychosocial circumstances of users of the Johanniter mobile support service.
時間枠：0 - 365 days
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Quantitative analysis of the psychosocial circumstances of users of the Johanniter-Hilfsmobil due to exceptional environmental influences, using a standardised questionnaire. The following metrics are to be collected:
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0 - 365 days
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Survey of the psychosocial circumstances and the environmental factors of which they are exposed of homeless people in Augsburg using the Johanniter-Hilfsmobil
時間枠：0-365 days
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As a final step, a qualitative analysis will be carried out through guided interviews with users of the Johanniter-Hilfsmobil to gain a deeper understanding of the quantitative findings regarding their psychosocial circumstances and the environmental factors to which they are exposed. The following categories will be covered in the personal interview with the homeless persons:
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0-365 days
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Difference in consumption patterns in relation to the season
時間枠：0 - 365 days
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In order to identify any seasonal variations in consumption patterns, a statistical analysis is carried out based on the results of saliva samples taken from drug-dependent individuals who present themselves either via the Johanniter-Hilfsmobil or via the substitution clinic at the Department of Psychiatry, Psychotherapy and Psychosomatics at Augsburg District Hospital.
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0 - 365 days
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協力者と研究者
出版物と役立つリンク
一般刊行物
- 1. Gerull S. Systematische Lebenslagenuntersuchung wohnungsloser Menschen 2018 [Available from: https://opus4.kobv.de/opus4-ash/frontdoor/index/index/docId/246 https://nbn-resolving.org/urn:nbn:de:kobv:b1533-opus-2465. 2. Gerull S. Wohnungslos in unsicheren Zeiten 2022 [1-57]. Available from: https://opus4.kobv.de/opus4-ash/frontdoor/index/index/docId/496 https://nbn-resolving.org/urn:nbn:de:kobv:b1533-opus-4961. 3. Gierveld JDJ, Tilburg TV. A 6-Item Scale for Overall, Emotional, and Social Loneliness:Confirmatory Tests on Survey Data. Research on Aging. 2006;28(5):582-98.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
本研究に関する用語
その他の研究ID番号
- 25-0578
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?
IPD プランの説明
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
米国FDA規制機器製品の研究
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