- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00214474
Improving Diabetes Efforts Across Language and Literacy (IDEALL)
12 febbraio 2013 aggiornato da: Agency for Healthcare Research and Quality (AHRQ)
The IDEALL Project (Improving Diabetes Efforts Across Language and Literacy) is a 3-arm randomized controlled trial to explore contextual factors at the patient, clinician, and organizational level of two patient self-management support strategies.
A communication technology-based intervention (automated telephone diabetes management) and an interpersonally-oriented intervention (group medical visits)will be compared to usual care for their ability to improve diabetes outcomes among vulnerable populations in 4 safety-net health centers in the University of California, San Francisco (UCSF) Collaborative Research Network.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
See above
Tipo di studio
Interventistico
Iscrizione (Effettivo)
339
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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California
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San Francisco, California, Stati Uniti, 94143-1364
- Ucsf Dept of Medicine Box 1364
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- have type 2 diabetes
- have a HbA1c equal to or > 8.0%
- must speak English, Spanish, or Cantonese.
Exclusion Criteria:
- Dementia
- Psychosis/Schizophrenia
- End Stage Renal Disease
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: ATSM Intervention
ATSM Intervention: Automated Telephone Self-Management Support
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Participants randomized to ATSM Intervention received weekly, automated (pre-recorded) telephone calls over 39 weeks (9 months).
Patient responses triggered either immediate, automated health education messages and/or subsequent nurse phone follow-up.
Altri nomi:
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Comparatore attivo: GMV Intervention
GMV Intervention: Group Medical Visits
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GMV Intervention involved 90-minute monthly sessions over 9 months, involving 6-10 participants, co-facilitated by a primary care physician and health educator.
Altri nomi:
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Nessun intervento: Usual Care
Usual Care: Standard care for diabetic patients
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Changes in Diabetes Self-management Behaviors as Measured by Summary of Diabetes Self-Care Activities (SDSCA) Scale
Lasso di tempo: Baseline and 1 year
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The Summary of Diabetes Self-Care Activities (SDSCA) Measure is a brief self-report questionnaire on diabetes self-management behaviors.
The questionnaire assesses the frequency with which a patient followed a diabetes routine over the prior 7 days in five domains: diet, exercise, blood-glucose testing, foot care, and medication adherence.
Based on SDSCA measure's author's recommendations, two separate scores can be derived: a Diabetes Self-management Behaviors score and a Self-reported Medication Adherence score.
The Diabetes Self-management Behaviors score is used in this study.
For this score, all items pertaining to diet, exercise, blood glucose testing, and foot care are averaged.
The result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior.
Change is calculated as 1-year score minus baseline score.
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Baseline and 1 year
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Changes in Minutes of Moderate Physical Activity
Lasso di tempo: Baseline and 1 year
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A measure of patients' physical activity is ascertained by asking patients the following question: "In the last 7 days, how many total minutes or hours did you do physical activity?
Like walking, house cleaning or gardening."
Number of minutes may range from 0 to 10080, with greater number of minutes indicating more physical activity.
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Baseline and 1 year
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Changes in Minutes of Vigorous Exercise
Lasso di tempo: Baseline and 1 year
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A measure of patients' vigorous exercise is ascertained by asking patients the following question: "In the last 7 days, how many total minutes or hours did you do the kind of exercise that makes you breathe hard, such as swimming, walking fast, or biking?"
Number of minutes may range from 0 to 10080, with greater number of minutes indicating more vigorous exercise.
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Baseline and 1 year
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Changes in Patient Assessment of Chronic Illness Care (PACIC)
Lasso di tempo: Baseline and 1 year
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The Patient Assessment of Chronic Illness Care (PACIC) is a 20-item patient report instrument that measures patients' perspectives on the structure of their care and collects patient reports on the extent to which they have received specific clinical services and actions during the past year that are aligned with the Chronic Care Model.
The scale is intended to assess the receipt of care that is patient-centered, proactive, planned and includes collaborative goal setting, problem-solving and follow-up support.
Each instrument item is scored on a 5-point scale ranging from 1 to 5 with higher score indicating better care.
Scores are transformed to a 100-point scale and averaged across all items to create a total scale score.
Change is calculated as 1-year score minus baseline score.
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Baseline and 1 year
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Changes in Diabetes Self-efficacy as Measured by Diabetes Quality Improvement Project's Patient Self-Management Scale
Lasso di tempo: Baseline and 1 year
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The Patient Self-Management Scale was derived from a questionnaire used in the Diabetes Quality Improvement Project.
The scale is designed to reflect patients' assessment of their ability to manage aspects of diabetes self-care in 5 separate areas (medication, diet, exercise, blood glucose monitoring, and foot care).
Respondents are asked how difficult over the past year has it been to follow exactly as their doctor who takes care of their diabetes suggested.
Possible scores for each scale item range from 0 to 100 with higher score indicating more self-efficacy.
Total scale score is calculated as the average across all items.
Change is calculated as 1-year score minus baseline score.
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Baseline and 1 year
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Changes in Interpersonal Processes of Care (IPC) Scale
Lasso di tempo: Baseline and 1 year
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The Interpersonal Processes of Care (IPC) captures patient reports of providers' communication over the prior year.
The scale is intended to measure patients' assessment of providers' communication within 3 broad domains: communication (e.g., lack of clarity), decision making (e.g., patient-centered decision making), and interpersonal style (e.g., friendliness).
Each instrument item is scored on a 5-point scale ranging from 1 to 5. Scores are transformed to a 100-point scale and averaged across all items to create a total scale score.
Higher total scores indicate better communication.
Change is calculated as 1-year score minus baseline score.
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Baseline and 1 year
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Changes in the Physical Component Summary of the SF-12 Health Survey
Lasso di tempo: Baseline and 1 year
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The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes.
The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being).
Two summary measures are derived: the Physical and the Mental Health Component Summary.
For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome.
Change is calculated as 1-year score minus baseline score.
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Baseline and 1 year
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Changes in the Mental Component Summary of the SF-12 Health Survey
Lasso di tempo: Baseline and 1 year
|
The SF-12 Health Survey (SF-12) is a 12-item short-form survey used to measure health status and monitor health outcomes.
The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being).
Two summary measures are derived: the Physical and the Mental Health Component Summary.
For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better functioning and outcome.
Change is calculated as 1-year score minus baseline score.
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Baseline and 1 year
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Number of Days Spent in Bed Due to Health Problems
Lasso di tempo: 1 year
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A measure of patients' functional status is ascertained by asking patients the following question: "In the last 30 days, how many days did your health keep you in bed all or most of the day?" Number of days may range from 0 to 30, with lower number of days indicating better functional status.
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1 year
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Proportion of Patients Reporting Diabetes Interference of Normal Daily Activities
Lasso di tempo: 1 year
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A measure of diabetes interference on patients is ascertained by asking patients the following question: "In the last 12 months, how often has your diabetes kept you from doing your normal daily activities, such as going to work, grocery shopping, and taking care of yourself and others?"
Responses consist of 6 possible options: "Always", "Almost Always", "Often", "Sometimes", "Almost Never", and "Never".
These responses are grouped into 2 categories, with one category consisting of "Always", "Almost Always", and "Often" responses while the other category consists of the remaining responses.
The proportion of patients reporting diabetes interference is the number of patients in the first category divided by the number of patients in the 2 categories combined.
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1 year
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Changes in Hemoglobin A1c Levels
Lasso di tempo: Baseline and 1 year
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Hemoglobin A1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
As the average amount of plasma glucose increases, the fraction of hemoglobin A1c increases in a predictable way.
This serves as a marker for average blood glucose levels over the previous months prior to the measurement.
Higher amounts of hemoglobin A1c indicate poorer control of blood glucose levels and have been associated with cardiovascular disease.
Change is calculated as 1-year level minus baseline level.
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Baseline and 1 year
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Changes in Systolic Blood Pressure (SBP)
Lasso di tempo: Baseline and 1 year
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Systolic blood pressure is the pressure exerted on arteries and vessels by the heart when it contracts and pushes blood through the arteries to the rest of the body.
Change is calculated as 1-year pressure minus baseline pressure.
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Baseline and 1 year
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Changes in Diastolic Blood Pressure (DBP)
Lasso di tempo: Baseline and 1 year
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Diastolic blood pressure is the pressure exerted on the walls of the arteries and vessels in between heart beats, when the heart is relaxed and dilated, filling with blood.
Change is calculated as 1-year pressure minus baseline pressure.
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Baseline and 1 year
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Changes in Body Mass Index (BMI)
Lasso di tempo: Baseline and 1 year
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Body Mass Index (BMI) is a number calculated from a person's weight and height.
BMI is defined as the individual's body mass divided by the square of their height.
The formulae used produce a unit of measure of kg/m2.
BMI provides an indicator of body fatness.
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Baseline and 1 year
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Dean Schillinger, MD, University of California, San Francisco
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 novembre 2002
Completamento primario (Effettivo)
1 novembre 2005
Completamento dello studio (Effettivo)
1 novembre 2005
Date di iscrizione allo studio
Primo inviato
19 settembre 2005
Primo inviato che soddisfa i criteri di controllo qualità
19 settembre 2005
Primo Inserito (Stima)
22 settembre 2005
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
13 febbraio 2013
Ultimo aggiornamento inviato che soddisfa i criteri QC
12 febbraio 2013
Ultimo verificato
1 febbraio 2013
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1R21HS014864-01 (Sovvenzione/contratto AHRQ degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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