Mind your medication: A randomized, controlled trial using a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF)

Mind your medication: A randomized, controlled trial using a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF) - TELEMED-HF

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35787

Enrollment

400

Registered

2011-04-20

Start date

2011-10-19

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiac failure heart failure

Interventions

Intervention: The intervention consists of the use of an electronic Medication Adherence Monitor for a 6-month period as well as 2 visits to the heart failure outpatient clinic of the TweeSteden hos

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Stable systolic heart failure - New York Heart Association functional class II-III, with a decreased pump function (left ventricular ejection fraction (LVEF)

Exclusion criteria

Exclusion criteria: - Diastolic heart failure (intact pump function) - Myocardial infarction, invasive treatment (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), or hospitalization within 1 month prior to inclusion - Life-threatening comorbid conditions (e.g., cancer) - Diminished mental capacities (suspected cognitive decline will be confirmed by a mini mental state examination (MMSE)) - History of psychiatric disorders apart from affective disorders (depression and anxiety disorders)

Design outcomes

Primary

Measure	Time frame
Primary: objective and subjective medication adherence, healthcare consumption, and costs.	—

Secondary

Measure	Time frame
Secondary: QoL, self-care behaviour, disease severity (NYHA class, LVEF), exercise capacity, number of hospitalizations. Other study parameters are included to determine whether randomization was successful, to assess their potentially moderating influence on adherence, and to generate risk profiles of patients who may/may not benefit from the intervention: Psychological and sociodemographic: Type D personality, depression, anxiety, quality of life, socio-economic status, age gender. Clinical: self-reported medication side effects, Left Ventricular Ejection Fraction (LVEF; echocardiography); time since heart failure diagnosis; heart failure etiology; previous cardiac events (MI), previous cardiac procedures (PCI, CABG), previous cardiac devices (ICD, pacemaker), hospitalizations for heart failure; NYHA functional class (structural interview); blood pressure; cholesterol; triglycerides; diabetes; atrial fibrillation; comorbidities; all cardiac medication, all other medication (incl. psychotropic medication); C-reactive protein; NT-pro-BNP; parameters measured in standard clinical practice (incl. liver function (ACAT, ALAT, Gamma GT), haemoglobin, hematocrit, leukocytes, and kidney function (urea and creatinine)). Cost-benefit analysis: The TiC-P questionnaire (developed by the Trimbos Institute22) and event rate (and related DBC (diagnosis treatment combination, the Dutch system to allocate costs to treatments of specific patient groups)) will enable us to compare healthcare consumption in the intervention and control group. In examining the healthcare consumption, we will also include the costs of the telecare support system and the medication adherence monitor.	—

Measure

Time frame

Secondary: QoL, self-care behaviour, disease severity (NYHA class, LVEF), exercise capacity, number of hospitalizations. Other study parameters are included to determine whether randomization was successful, to assess their potentially moderating influence on adherence, and to generate risk profiles of patients who may/may not benefit from the intervention: Psychological and sociodemographic: Type D personality, depression, anxiety, quality of life, socio-economic status, age gender. Clinical: self-reported medication side effects, Left Ventricular Ejection Fraction (LVEF; echocardiography); time since heart failure diagnosis; heart failure etiology; previous cardiac events (MI), previous cardiac procedures (PCI, CABG), previous cardiac devices (ICD, pacemaker), hospitalizations for heart failure; NYHA functional class (structural interview); blood pressure; cholesterol; triglycerides; diabetes; atrial fibrillation; comorbidities; all cardiac medication, all other medication (incl. psychotropic medication); C-reactive protein; NT-pro-BNP; parameters measured in standard clinical practice (incl. liver function (ACAT, ALAT, Gamma GT), haemoglobin, hematocrit, leukocytes, and kidney function (urea and creatinine)). Cost-benefit analysis: The TiC-P questionnaire (developed by the Trimbos Institute22) and event rate (and related DBC (diagnosis treatment combination, the Dutch system to allocate costs to treatments of specific patient groups)) will enable us to compare healthcare consumption in the intervention and control group. In examining the healthcare consumption, we will also include the costs of the telecare support system and the medication adherence monitor.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)