Medium Term Health Coaching and Life-long Monitoring in Cardiovascular Disease in Norrbotten
Primary Purpose
Diabetes, Heart Disease, Quality of Life
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Health Coaching and Life-long Monitoring
Sponsored by

About this trial
This is an interventional supportive care trial for Diabetes focused on measuring Promotion health
Eligibility Criteria
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
Sites / Locations
- Luleå University of Technology
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard care
Health coaching and and Life-long Monitoring
Arm Description
Outcomes
Primary Outcome Measures
SF-36
Questionnaire, 36 questions ref Ware, 2000 version 2
Secondary Outcome Measures
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.
Bloodpressure
Blood lipids
Bodyweight
Smoking habits
Alcohol consumption
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.
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.
Full Information
NCT ID
NCT01478672
First Posted
November 2, 2011
Last Updated
November 21, 2011
Sponsor
Luleå Tekniska Universitet
Collaborators
County Council of Norrbotten, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT01478672
Brief Title
Medium Term Health Coaching and Life-long Monitoring in Cardiovascular Disease in Norrbotten
Official Title
Medium Term Health Coaching and Life-long Monitoring in Cardiovascular Disease in Norrbotten
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Luleå Tekniska Universitet
Collaborators
County Council of Norrbotten, Sweden
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Heart Disease, Quality of Life
Keywords
Promotion health
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
741 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard care
Arm Type
No Intervention
Arm Title
Health coaching and and Life-long Monitoring
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Health Coaching and Life-long Monitoring
Intervention Description
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 Outcome Measure Information:
Title
SF-36
Description
Questionnaire, 36 questions ref Ware, 2000 version 2
Time Frame
12 months follow-up
Secondary Outcome Measure Information:
Title
HbA1c (for patients with type-2D) Blood pressure for patient with heart disease
Description
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.
Time Frame
12 months follow-up
Title
Bloodpressure
Time Frame
12 months follow-up
Title
Blood lipids
Time Frame
12 months follow-up
Title
Bodyweight
Time Frame
12 months follow-up
Title
Smoking habits
Time Frame
12 months follow-up
Title
Alcohol consumption
Time Frame
12 months follow-up
Title
SOC-13
Description
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.
Time Frame
12 months follow-up
Title
EQ-5D
Description
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.
Time Frame
12 monts follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Luleå University of Technology
City
Luleå
ZIP/Postal Code
971 87
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
30291058
Citation
Lindberg I, Torbjornsen A, Soderberg S, Ribu L. Telemonitoring and Health Counseling for Self-Management Support of Patients With Type 2 Diabetes: A Randomized Controlled Trial. JMIR Diabetes. 2017 Jun 26;2(1):e10. doi: 10.2196/diabetes.6884.
Results Reference
derived
Links:
URL
http://www.renewinghealth.eu/
Description
RENEWING HEALTH, REgioNs of Europe WorkINg toGether for HEALTH Click here for more information about this study:"
Learn more about this trial
Medium Term Health Coaching and Life-long Monitoring in Cardiovascular Disease in Norrbotten
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