- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01245686
Heart to Health: A Combined Lifestyle and Medication Intervention to Reduce Cardiovascular Disease (CVD) Risk
A Combined Lifestyle and Medication Intervention to Reduce CVD Risk
Cardiovascular disease (CVD), including heart disease and stroke, is the leading cause of death in the US. Every year, more than one million Americans have a heart attack, and nearly 800,000 have a stroke. In 2010, heart disease alone is expected to cost the country more than $316 billion in health care and lost productivity.
Both lifestyle changes and medication can reduce the risk of CVD, and this project combines these approaches in the hopes of identifying a practical intervention for use in primary care medical offices. The project combines two previously tested interventions and updates them to meet current guidelines for diet and use of aspirin and cholesterol-controlling drugs (statins).
The research team is delivering the combined intervention in two formats: web-based and counselor-based. Each format has the same content, but the web-based advice is accessed through the Internet by clients at home, a community site, or a primary care office. The other format involves sessions delivered to clients by a counselor either in person at a primary care office or over the telephone. The researchers will compare how effective each format is in reducing participants' risk of coronary heart disease. They will also determine the interventions' effect on participants' diet, physical activity, smoking status, medication adherence, and other health indicators. In addition, the team will compare the two formats' cost-effectiveness and how well the patients, office staff, and clinicians accept the interventions.
Recruited from five family practices, 600 patients representing the geographic and ethnic diversity of North Carolina are taking part in this study. Half the participants are randomly assigned to the web-based intervention; the other half to the counselor-based version. Both groups will also get information on local resources, such as gyms and farmers markets, that can help participants maintain a healthy lifestyle.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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North Carolina
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Durham, North Carolina, Stati Uniti, 27704
- Durham Family Practice
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Eden, North Carolina, Stati Uniti, 27288
- Dayspring Family Medicine
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Kannapolis, North Carolina, Stati Uniti, 28081
- Cabarrus Family Medicine Residency
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Moncure, North Carolina, Stati Uniti, 27559
- Moncure Community Health Center
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Yanceyville, North Carolina, Stati Uniti, 27379
- Caswell Family Medical Clinic
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Established patients
- Men ages 35-79
- Women ages 45-79
- History of CVD (100 participants)
- CHD risk equal or greater than 10%
- elevated CHD risk factor
Exclusion Criteria:
- non-English speaking
- no phone
- treatment of psychosis
- history of alcohol/substance abuse within last 2 years
- pregnancy, breast feeding, or anticipated pregnancy in next 18 months
- history of malignancy, other than non-melanoma skin cancer, that has not been in remission or cured surgically for >5 years
- recent history (in past year) of hypoglycemic event requiring medical attention
- estimated creatinine clearance less than 30 ml/min
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- 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: One-on-one counseling
Participants in this arm will receive 4 intensive one-on-one counseling sessions (either in person or on the phone) and 3 brief maintenance sessions.
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The Heart to Health Intervention combines and enhances two previously tested interventions to reduce CVD risk (a counselor-based intervention to improve lifestyle and a web-based intervention to improve medication adherence).
The new lifestyle and medication adherence intervention (delivered alternately in a one-on-one counseling or web-format) includes a decision aid on heart disease risk and risk-reducing options, general education on lifestyle and medication adherence, tips for overcoming barriers to CHD risk reduction, and goal setting and specification of first steps.
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Comparatore attivo: Web counseling
Participants in this arm will receive 4 intensive counseling sessions over the web.
They will also receive 3 maintenance sessions over the web.
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The Heart to Health Intervention combines and enhances two previously tested interventions to reduce CVD risk (a counselor-based intervention to improve lifestyle and a web-based intervention to improve medication adherence).
The new lifestyle and medication adherence intervention (delivered alternately in a one-on-one counseling or web-format) includes a decision aid on heart disease risk and risk-reducing options, general education on lifestyle and medication adherence, tips for overcoming barriers to CHD risk reduction, and goal setting and specification of first steps.
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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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Predicted 10-year CHD risk
Lasso di tempo: 4-month follow-up
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Framingham risk scores are well-validated and provide an absolute estimate of the likelihood of CHD events (MI, angina, and CHD death) over a 10-year time period. We will examine absolute changes in this outcome in both intervention arms. We will also examine whether this outcome varies by subgroups of the following variables: baseline level of predicted CHD risk, age, race, SES, insurance status, overall health status, numeracy, literacy, # medications, # of perceived barriers to adherence, use of the intervention, time with the intervention, study practice site, and health counselor |
4-month follow-up
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Predicted 10-year CHD risk
Lasso di tempo: 12 months
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Framingham risk scores are well-validated and provide an absolute estimate of the likelihood of CHD events (MI, angina, and CHD death) over a 10-year time period.
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12 months
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Use of and adherence to cardiovascular medicines
Lasso di tempo: 4 and 12 months
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Use of cardiovascular medicines will be by self-report. Adherence to cardiovascular medicines will be measured by the 8-Item Morisky scale and a single-item specifying overall percentage adherence to cardiovascular medicines(categorical). Participants will additionally report use of and adherence to individual medicines, including aspirin, blood pressure medicine, and cholesterol medicine. Aspirin adherence will be validated by serum thromboxane b2 in a subsample of participants. Blood pressure and cholesterol medicine use will be confirmed by changes in blood pressure and cholesterol. |
4 and 12 months
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Dietary Intake
Lasso di tempo: 4 and 12 months
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Dietary intake will be measured through a combination of self-report and objective measures.
Participants will self-report diet on two validated questionnaires: the block questionnaire (fruit and vegetable intake) and the fat quality screener.
Fruit and vegetable intake will be objectively measured by serum carotenoids.
Fat quality will be objectively measured using RBC membrane fatty acids.
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4 and 12 months
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Physical activity
Lasso di tempo: 4 and 12 months
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Physical activity will be measured through a combination of self-report and objective measures.
Participants will report physical activity on the validated modified RESIDE questionnaire.
They will additionally wear a pedometer to monitor their daily total and aerobic steps.
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4 and 12 months
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Blood pressure
Lasso di tempo: 4 and 12 months
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Blood pressure will be measure via standardized protocol using an oscillometric automatic monitor
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4 and 12 months
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Total, HDL, and direct LDL cholesterol
Lasso di tempo: 4 and 12 months
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Total, HDL, and direct LDL cholesterol will be measured via enzymatic calorametric testing.
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4 and 12 months
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Smoking status
Lasso di tempo: 4 and 12 months
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Smoking will be measured through a combination of self-report and urinary cotinine (Nicalert test strips).
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4 and 12 months
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Adverse events
Lasso di tempo: 4 and 12 months
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We will monitor the following adverse events: ED visits (self-report), hospitalizations (self-report), deaths (family report confirmed by death registry), GI bleeds (self-report), hemorrhagic stroke (self-report), musculoskeletal injury (self-report), renal dysfunction (serum creatinine), and liver dysfunction (AST).
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4 and 12 months
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Acceptability of the Intervention
Lasso di tempo: 4 and 12 months
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We will measure the acceptability of the intervention using process measures querying participants, office staff, and clinicians about the perceptions of the acceptability of the intervention and the time to deliver it.
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4 and 12 months
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Cost-effectiveness
Lasso di tempo: 4 and 12 months
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We will measure the cost-unit CHD risk reduction for the two interventions using a societal perspective.
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4 and 12 months
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Thomas C Keyserling, MD, MPH, UNC-Chapel Hill
- Direttore dello studio: Stacey L Sheridan, MD, MPH, UNC-Chapel Hill
Pubblicazioni e link utili
Pubblicazioni generali
- Keyserling TC, Sheridan SL, Draeger LB, Finkelstein EA, Gizlice Z, Kruger E, Johnston LF, Sloane PD, Samuel-Hodge C, Evenson KR, Gross MD, Donahue KE, Pignone MP, Vu MB, Steinbacher EA, Weiner BJ, Bangdiwala SI, Ammerman AS. A comparison of live counseling with a web-based lifestyle and medication intervention to reduce coronary heart disease risk: a randomized clinical trial. JAMA Intern Med. 2014 Jul;174(7):1144-57. doi: 10.1001/jamainternmed.2014.1984.
- Sheridan SL, Draeger LB, Pignone MP, Sloane PD, Samuel-Hodge C, Finkelstein EA, Gizlice Z, Vu MB, Gitterman DP, Bangdiwala SI, Donahue KE, Evenson K, Ammerman AS, Keyserling TC. Designing and implementing a comparative effectiveness study of two strategies for delivering high quality CHD prevention: methods and participant characteristics for the Heart to Health study. Contemp Clin Trials. 2013 Nov;36(2):394-405. doi: 10.1016/j.cct.2013.07.013. Epub 2013 Aug 2. Erratum In: Contemp Clin Trials. 2014 Jul;38(2):420-3.
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Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 10-2028
- 1U48DP002658 (Sovvenzione/contratto NIH 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 .
Prove cliniche su Lifestyle and medication intervention
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Indiana UniversityUniversity of South Florida; National Institute on Minority Health and Health... e altri collaboratoriCompletatoIntervento DECIDE modificato | Trattamento come consueto gruppo di curaStati Uniti
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access LivingAttivo, non reclutante
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VA Office of Research and DevelopmentRitiratoDisturbi del sonno e della veglia | Disturbi del sonno | Disturbi legati al sonnoStati Uniti