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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01478672
• Other study ID #: LTU-Medium health coaching
• Status: Completed
• Phase: N/A
• First received: November 2, 2011
• Last updated: November 21, 2011
• Start date: March 2011
• Est. completion date: September 2011

Study information

• Verified date: November 2011
• Source: Luleå Tekniska Universitet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 741
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes
• Heart Disease
• Quality of Life

Intervention

Procedure:
• Health Coaching and Life-long Monitoring
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

Locations

Country	Name	City	State
Sweden	Luleå University of Technology	Luleå

Sponsors (2)

Lead Sponsor	Collaborator
Luleå Tekniska Universitet	County Council of Norrbotten, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SF-36	Questionnaire, 36 questions ref Ware, 2000 version 2	12 months follow-up	No
Secondary	HbA1c (for patients with type-2D) Blood pressure for patient with heart disease	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.	12 months follow-up	No
Secondary	Bloodpressure		12 months follow-up	No
Secondary	Blood lipids		12 months follow-up	No
Secondary	Bodyweight		12 months follow-up	No
Secondary	Smoking habits		12 months follow-up	No
Secondary	Alcohol consumption		12 months follow-up	No
Secondary	SOC-13	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.	12 months follow-up	No
Secondary	EQ-5D	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.	12 monts follow-up	No

External Links

•   RENEWING HEALTH, REgioNs of Europe WorkINg toGether for HEALTH Click here for more information about this study:"