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OpenTrials
Completed

NCT Number: NCT01478672

Medium Term Health Coaching and Life-long Monitoring in Cardiovascular Disease in Norrbotten

The purpose of this study is to evaluate whether the introduction of large-scale personalized and technology supported telemonitoring and health coaching interventions produces benefits in terms of health related quality of life, health status and empowerment of patients with a cardiovascular disease. In addition, the trials evaluate the economical and organizational impact of the new services and examine their acceptability by patients and health professionals.

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Key information

Conditions

Diabetes Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Disease Heart Diseases Metabolic Diseases Nutritional and Metabolic Diseases Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Luleå University of Technology

Luleå, 971 87, Sweden

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of arterial hypertension ischemic heart disease,
  • atrial fibrillation or other arrhythmia,
  • congestive heart failure (study heart disease)
  • HbA1C > 53mmol/mol (study diabetes)
  • Age > 18 years
  • Capability of filling in questionnaires in the own language
  • Capability to use the devices provided
  • Being cognitively able to participate

Treatment and study plan

Health Coaching and Life-long Monitoring

Procedure

Participants receive tablet PCs with software that collects and transmit diagnostic measurements. Measurements are performed by the participants following indications of the health coaching team. Equipment used by all participants: • blood pressure meter, • pedometer • pulse watch• 2-channel electrocardiograph. Measured values are entered manually by the participants, unrealistic values are refused and values are provided with a time-stamp. Measurements is reviewed in a graphical display. Measured values are accessed by the health coaching team that develops an individualized measurement and medication scheme. Reminders are provided by the software and can be exported to personal calendars or mobile phones. Secure authentication of users is be provided

Primary outcomes

  1. SF-36

    Time frame: 12 months follow-up

    Questionnaire, 36 questions ref Ware, 2000 version 2

Secondary outcomes

  1. HbA1c (for patients with type-2D) Blood pressure for patient with heart disease

    Time frame: 12 months follow-up

    HbA1c is a long-term sugar / serum glucose test, it is a blood test that gives a measure of blood sugar levels two to three months before sampling.

  2. Bloodpressure

    Time frame: 12 months follow-up

  3. Blood lipids

    Time frame: 12 months follow-up

  4. Bodyweight

    Time frame: 12 months follow-up

  5. Smoking habits

    Time frame: 12 months follow-up

  6. Alcohol consumption

    Time frame: 12 months follow-up

  7. SOC-13

    Time frame: 12 months follow-up

    SOC-13 (sense of coherence, SOC) is a term that reflects the ability to cope with stress and is the essence of the salutogenic theory of health. SOC consists of three subordinate concepts, manageability, meaningfulness and comprehensibility.

  8. EQ-5D

    Time frame: 12 monts follow-up

    EQ5D (5d) is a standardized instrument to measure and describe health outcomes. It can be used to measure health at the individual level in clinical settings and to measure a population's health locally and nationally.

Sponsors and collaborators

Lead sponsor

Luleå Tekniska Universitet

Other

Collaborators

  • County Council of Norrbotten, Sweden

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Nov 23, 2011
Registry last updated
Nov 23, 2011

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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