Proactive Health Support
4. februar 2020 opdateret af: Ulla Toft, Frederiksberg University Hospital
Proactive Health Support - a Randomized Controlled Trial of Telephone-based Self-management Support
Proactive Health Support is a randomized controlled trial of telephone-based self-management support.
The primary aim of the intervention is to reduce hospital admissions and improve quality of life in patients with a high risk of hospital admission.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Participants are identified through an algorithm, that assigns each patient with a risk score of 0-100%.
Patients with the highest risk in each of the five regions of Denmark are invited to participate.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
5454
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Frederiksberg, Danmark
- Center for Clinical Research and Prevention
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Persons with a hospital contact within the last year caused by ≥ 1 of the following diagnoses: heart diseases (DI110, DI130, DI132, DI50), connective tissue diseases (DD86, DM05, DM06, DM08, DM09, DM30, DM31, DM32, DM33, DM34, DM35, DM36), pulmonary diseases (DJ40, DJ41, DJ42, DJ43, DJ44, DJ45, DJ46, DJ47, DJ60, DJ61, , DJ62, DJ63, DJ64, DJ65, DJ66, DJ67, DJ684, DJ701, DJ703, DJ841, DJ842, DJ843, DJ848, DJ849, DJ920, DJ961, DJ982, DJ983) or diabetes (DE10, DE11, DE14) Or
- Persons ≥ 18 years and ≥ three unplanned hospital admissions in the last six months Or
- Persons ≥ 65 years with a preventable hospital admission (predefined diagnoses: dehydration, constipation, lower respiratory tract infections, urinary tract infections, gastroenteritis, fractures, nutrition deficiency anemia, social causes and pressure ulcers) or a readmission (within 30 days)
Exclusion Criteria:
- Selected psychiatric diagnoses: substance abuse disorder (DF1), schizophrenia (DF2) or dementia (DF00, DF01, DF02, DF03, DF051)
- Metastatic cancer (DC77, DC78, DC79, DC80)
- Assisted living Facility
- Documented terminal illness or life expectancy < one year
- Assessment of dementia
- Major surgery planned within 6 months
- Hearing impairment
- Not speaking Danish
- Cognitive impairment
- Substance abuse, that impairs adherence
- No telephone
- Receiving similar trial intervention
- Other (including intervention not suitable)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: Sædvanlig pleje
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Eksperimentel: Proactive Health Support
The purpose of the intervention is to enhance patients' self-management strategies and thereby enable patients to cope with illness at home and prevent the development of those conditions, that are sensitive to preventive efforts.The intervention includes active listening, coaching and counselling and elements from case management such as assessing the need for healthcare services.
Emphasis is on supporting and empowering the patient to make the necessary contacts to healthcare professionals.
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Active listening, coaching and counselling
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Hospitaloptagelser
Tidsramme: 6 måneder
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6 måneder
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Quality of life
Tidsramme: 6 months
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Questionnaire SF 36 - Mental Health Composite Score (Norm-based T-score of 45-55 is considered normal)
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6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Overlevelse
Tidsramme: 1 år
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1 år
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Patient education
Tidsramme: 3, 6 and 12 months
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Questionnaire Hei-Q - all 8 subscales (health-directed activities, positive and active engagement in life, emotional distress, self-monitoring and insight, constructive attitudes and approaches, skill and technique acquisition, social integration and support, health service navigation, range 1-4)
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3, 6 and 12 months
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Outpatient consultations
Tidsramme: 3, 6 and 12 months
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3, 6 and 12 months
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Use of primary healthcare
Tidsramme: 3, 6 and 12 months
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3, 6 and 12 months
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Use of prescription medication
Tidsramme: 3, 6 and 12 months
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3, 6 and 12 months
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Quality of life
Tidsramme: 3, 6 and 12 months
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Questionnaire SF36: All eight subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health and health transition, range 0-100.
Furthermore, norm-based T-scores are reported, 45-55 is considered normal) and two composite scores (mental and physical health, norm-based T-score of 45-55 is considered normal)
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3, 6 and 12 months
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Incremental cost effectiveness ratio by comparison of costs with quality adjusted life years
Tidsramme: 3, 6 and 12 months
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3, 6 and 12 months
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Regional differences in resource use and costs
Tidsramme: 3, 6 and 12 months
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3, 6 and 12 months
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Resource use in primary care and rehabilitation
Tidsramme: 3, 6 and 12 months
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3, 6 and 12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Ulla Toft, PhD, Frederiksberg University Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
9. april 2018
Primær færdiggørelse (Faktiske)
1. februar 2020
Studieafslutning (Faktiske)
1. februar 2020
Datoer for studieregistrering
Først indsendt
1. august 2018
Først indsendt, der opfyldte QC-kriterier
9. august 2018
Først opslået (Faktiske)
14. august 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. februar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. februar 2020
Sidst verificeret
1. februar 2020
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- SJ-677
Plan for individuelle deltagerdata (IPD)
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