- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01390272
Titrated Disease Management for Patients With Hypertension (TDM)
Randomized Trial of Titrated Disease Management for Patients With Hypertension
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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North Carolina
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Durham, North Carolina, Forente stater, 27705
- Durham VA Medical Center, Durham, NC
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age >= 18 years.
- Assigned primary care provider in one of the clinics of the Durham VA Medical Center (VAMC) (including Community Based Outpatient Clinics for example - Hillandale Clinic and Greenville (CBOC)).
- Had at least 1 primary care visit at the Durham VA or affiliated CBOC in the last year.
- Diagnosis of hypertension requiring medication, as determined by: ICD 401.0, 401.1, or 401.9 for >= 2 outpatient encounters during the prior year and Received a prescription for at least 1 of the following classes of hypertensive medication in the previous year: 1) ACE inhibitors; 2) alpha blockers; 3) angiogenesis II inhibitors; 4) beta blockers; 5) calcium channel blockers; 6) diuretics; 7) antihypertensive combination; and/or 8) antihypertensives, other.
- Out of control systolic blood pressure: Durham VAMC (including CBOCs or other affiliated clinics captured in the Durham VAMC electronic health record) outpatient BP measurements >= 150 mmHg for non-diabetic or >= 140 mmHg for diabetic patients over the last year and last systolic BP measurement >= 140 mmHg for non-diabetic or >= 130 mmHg for diabetic patients. If additional patients need to be approached to be offered the opportunity for further screening, non-diabetic patients with mean outpatient systolic BP of >= 140 mmHg or diabetic patients with mean outpatient systolic BP of >= 130 mmHg over the past year may be approached.
Patients must indicate that they both:
- Have a VA or affiliated clinic provider that they consider to be their main PCP.
- Receive the majority of healthcare at the Durham VA Medical Center (or affiliated clinic - such as Hillandale or Greenville).
Exclusion Criteria:
- Active diagnosis of psychosis.
- Diagnosis of metastatic cancer.
- Type 1 diabetes
- Class IV congestive heart failure (CHF).
- Currently receiving kidney dialysis or if estimated glomerular filtration rate (eGFR) levels are <= 15.
- Chronic obstructive pulmonary disease (COPD) requiring oxygen.
- Resident in nursing home or receiving home healthcare.
- Patient is pregnant or reports planning to become pregnant in the next two years
- At the time of potential enrollment, participating in another ongoing hypertension, diabetes, cholesterol, or cardiovascular disease clinical trial.
- Planning to leave the area prior to the anticipated end of participation.
- Inability or unwillingness to come to the Durham VAMC or affiliated clinic such as Hillandale or Greenville for baseline-, 6-, 12-, and 18-month study visits.
- Does not have reasonable access to a telephone.
- Does not speak English.
- Severely impaired hearing or speech (Patients must be able to respond to phone calls.).
- Severely impaired vision (Patients must be able to read mailed material).
- Refusal or inability to provide informed consent and HIPAA authorization form.
- Arm size > 50 cm
- Unable to obtain (including by arm) valid blood pressure readings
- Inadequate mental status to complete the protocol, as judged by five or more errors on the Short Portable Mental Status Questionnaire (SPMSQ).
- Former, current or pending solid organ or bone marrow transplant patient.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Titration Intervention
The intervention arm includes three levels of resource intensity targeted to improve patients' systolic blood pressure (SBP) [top number of blood pressure measurement]. Medium/level 1 resource intensity: a registered nurse (RN) will provide monthly tailored behavioral support telephone calls + home BP monitoring. High/level 2 resource intensity: a pharmacist will provide monthly tailored behavioral support telephone calls + home BP monitoring + pharmacist-directed medication management. Booster (low) resource intensity: a licensed practical nurse (LPN) will provide non-tailored behavioral support telephone calls every two months to patients whose SBP comes under control. |
A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months.
Andre navn:
Monthly tailored RN delivered calls + home BP monitoring.
Andre navn:
Pharmacist delivered telephone behavioral self-management support + Home BP monitoring with feedback to pharmacist + Algorithmic medication changes directed by pharmacist (with physician backup).
Andre navn:
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Aktiv komparator: LPN Control
A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months (identical to booster (low) resource intensity component of the titrated intervention).
The control arm will utilize the same procedures as the booster level for intervention patients for whom SBP comes under control.
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A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Systolic Blood Pressure
Tidsramme: Baseline
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Continuous change in systolic blood pressure was measured as the primary outcome.
Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the baseline study visits.
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Baseline
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Systolic Blood Pressure
Tidsramme: 6 months
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Continuous change in systolic blood pressure was measured as the primary outcome.
Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the 6- month study visits.
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6 months
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Systolic Blood Pressure
Tidsramme: 12 months
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Continuous change in systolic blood pressure was measured as the primary outcome.
Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the12-month study visits.
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12 months
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Systolic Blood Pressure
Tidsramme: 18 months
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Continuous change in systolic blood pressure was measured as the primary outcome.
Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the18- month study visits.
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18 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Hypertension Control
Tidsramme: Baseline
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The investigators examined the difference in the degree of systolic BP control over the 18 months of the study between the intervention and control arms.
Control was defined as SBP < 130mmHg for hypertensive patients with diabetes and < 140mmHg for patients without diabetes.
Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the baseline study visit.
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Baseline
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Number of Participants With Hypertension Control
Tidsramme: 6 months
|
The investigators examined the difference in the degree of systolic BP control over the 18 months of the study between the intervention and control arms.
Control was defined as SBP < 130mmHg for hypertensive patients with diabetes and < 140mmHg for patients without diabetes.
Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the 6-month study visit.
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6 months
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Number of Participants With Hypertension Control
Tidsramme: 12 months
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The investigators examined the difference in the degree of systolic BP control over the 18 months of the study between the intervention and control arms.
Control was defined as SBP < 130mmHg for hypertensive patients with diabetes and < 140mmHg for patients without diabetes.
Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the 12-study visit.
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12 months
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Number of Participants With Hypertension Control
Tidsramme: 18 months
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The investigators examined the difference in the degree of systolic BP control over the 18 months of the study between the intervention and control arms.
Control was defined as SBP < 130mmHg for hypertensive patients with diabetes and < 140mmHg for patients without diabetes.
Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the18- month study visit.
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18 months
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Cost Effectiveness
Tidsramme: Over 18 months of study intervention
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One of our secondary research questions was: "If the intervention results in greater reduction in SBP than the control group, is it cost effective?" Intervention results did not show statistically significant differences between arms, therefore cost effectiveness analysis was not appropriate. While cost effectiveness was not analyzed because it was a null trial, the investigators would have used resource utilization and cost data from VA data sets to measure VA outpatient and inpatient utilization and costs by arms over 18 months. The investigators would have examined hypertension-related outpatient pharmacy prescription counts and costs in order to compare them to total outpatient pharmacy costs and the investigators would have examined inpatient utilization and costs. |
Over 18 months of study intervention
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Number of Participants Who Did Not Achieve Medication Adherence
Tidsramme: Baseline
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The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:
A response of YES to any one of the 4 items indicated non-adherence, and responses of all no indicated adherence. The numbers in the descriptive tables reflect number non-adherent. |
Baseline
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Number of Participants Who Did Not Achieve Medication Adherence
Tidsramme: 6 months
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The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:
A response of YES to any one of the 4 items indicated non-adherence, and responses of all no indicated adherence. The numbers in the descriptive tables reflect number non-adherent. |
6 months
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Number of Participants Who Did Not Achieve Medication Adherence
Tidsramme: 12 months
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The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:
A response of YES to any one of the 4 items indicated non-adherence, and responses of all no indicated adherence. The numbers in the descriptive tables reflect number non-adherent. |
12 months
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Number of Participants Who Did Not Achieve Medication Adherence
Tidsramme: 18 months
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The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:
A response of YES to any one of the 4 items indicated non-adherence, and responses of all no indicated adherence. The numbers in the descriptive tables reflect number non-adherent. |
18 months
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: George L Jackson, PhD MHA, Durham VA Medical Center, Durham, NC
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Jackson GL, Weinberger M, Kirshner MA, Stechuchak KM, Melnyk SD, Bosworth HB, Coffman CJ, Neelon B, Van Houtven C, Gentry PW, Morris IJ, Rose CM, Taylor JP, May CL, Han B, Wainwright C, Alkon A, Powell L, Edelman D. Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics. Contemp Clin Trials. 2016 Sep;50:5-15. doi: 10.1016/j.cct.2016.07.009. Epub 2016 Jul 12.
- Jackson GL, Stechuchak KM, Weinberger M, Bosworth HB, Coffman CJ, Kirshner MA, Edelman D. How Views of the Organization of Primary Care Among Patients with Hypertension Vary by Race or Ethnicity. Mil Med. 2018 Sep 1;183(9-10):e583-e588. doi: 10.1093/milmed/usx111.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IIR 10-383
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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