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Completed

NCT Number: NCT01390272

Titrated Disease Management for Patients With Hypertension

This randomized clinical trial examines whether programs aimed at matching resources to patient hypertension (i.e. high blood pressure) control lead to greater reduction in systolic blood pressure (top number of blood pressure reading) than simply having maintenance phone calls in addition to usual care. Answering this question will provide important evidence concerning the overall goal of sustained long-term implementation of the disease management programs as part of patient aligned care teams in the Veterans Affairs and other healthcare systems.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

About this study

Project Objectives: The investigators are conducting a two-arm 18-month randomized clinical trial for patients with pharmaceutically treated hypertension for which systolic BP is not controlled (>/=140 mmHg for non-diabetic or >/=130 mmHg for diabetic patients). The primary aim will be to compare two treatment arms/strategies in terms of impact on systolic BP control: Arm 1 - An intervention arm using titrated disease management in which patients' hypertension control, assessed at baseline, 6 and 12 months, will be used to decide the resource intensity of strategies: 1) Medium/level 1 resource intensity strategy: a registered nurse will provide monthly tailored behavioral support telephone calls + home BP monitoring; 2) High/level 2 resource intensity strategy: a pharmacist will provide monthly tailored behavioral support telephone calls + home BP monitoring + pharmacist-directed medication management; and 3) Booster (low) resource intensity strategy: a license practice nurse (LPN) will provide bi-monthly, non-tailored behavioral support telephone calls to patients whose systolic BP comes under control. Arm 2 - A control arm, in which an LPN will provide bi-monthly non-tailored behavioral support telephone calls (same procedures as the booster (low) resource intensity strategy component of the titrated intervention).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Booster/ low resource

Behavioral

A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months.

Other names: Control Arm - Low resource

Medium/Level 1 resource intensity

Behavioral

Monthly tailored RN delivered calls + home BP monitoring.

Other names: Intervention Arm - Level 1

High/Level 2 resource intensity

Behavioral

Pharmacist delivered telephone behavioral self-management support + Home BP monitoring with feedback to pharmacist + Algorithmic medication changes directed by pharmacist (with physician backup).

Other names: Intervention Arm - Level 2

Primary outcomes

  1. Systolic Blood Pressure

    Time frame: Baseline

    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.

  2. Systolic Blood Pressure

    Time frame: 6 months

    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.

  3. Systolic Blood Pressure

    Time frame: 12 months

    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.

  4. Systolic Blood Pressure

    Time frame: 18 months

    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.

Secondary outcomes

  1. Number of Participants With Hypertension Control

    Time frame: Baseline

    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.

  2. Number of Participants With Hypertension Control

    Time frame: 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.

  3. Number of Participants With Hypertension Control

    Time frame: 12 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 12-study visit.

  4. Number of Participants With Hypertension Control

    Time frame: 18 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 the18- month study visit.

  5. Cost Effectiveness

    Time frame: Over 18 months of study intervention

    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.

  6. Number of Participants Who Did Not Achieve Medication Adherence

    Time frame: Baseline

    The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:

    • Do you ever forget to take your blood pressure medicine?
    • Are you careless at times about taking your blood pressure medicine?
    • When you feel better do you sometimes stop taking you blood pressure medicine?
    • Sometimes if you feel worse when you take your blood pressure medicine, do you stop taking it? The scale is a Yes(0) or No (1) answer.

    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.

  7. Number of Participants Who Did Not Achieve Medication Adherence

    Time frame: 6 months

    The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:

    • Do you ever forget to take your blood pressure medicine?
    • Are you careless at times about taking your blood pressure medicine?
    • When you feel better do you sometimes stop taking you blood pressure medicine?
    • Sometimes if you feel worse when you take your blood pressure medicine, do you stop taking it? The scale is a Yes(0) or No (1) answer.

    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.

  8. Number of Participants Who Did Not Achieve Medication Adherence

    Time frame: 12 months

    The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:

    • Do you ever forget to take your blood pressure medicine?
    • Are you careless at times about taking your blood pressure medicine?
    • When you feel better do you sometimes stop taking you blood pressure medicine?
    • Sometimes if you feel worse when you take your blood pressure medicine, do you stop taking it? The scale is a Yes(0) or No (1) answer.

    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.

  9. Number of Participants Who Did Not Achieve Medication Adherence

    Time frame: 18 months

    The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:

    • Do you ever forget to take your blood pressure medicine?
    • Are you careless at times about taking your blood pressure medicine?
    • When you feel better do you sometimes stop taking you blood pressure medicine?
    • Sometimes if you feel worse when you take your blood pressure medicine, do you stop taking it? The scale is a Yes(0) or No (1) answer.

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Randomized Trial of Titrated Disease Management for Patients With Hypertension

Acronym: TDM

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 11, 2011
Registry last updated
Feb 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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