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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01478672
Enrollment
741
Registered
2011-11-23
Start date
2011-03-31
Completion date
2011-09-30
Last updated
2011-11-23

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

Conditions

Diabetes, Heart Disease, Quality of Life

Keywords

Promotion health

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.

Interventions

PROCEDUREHealth 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

Sponsors

County Council of Norrbotten, Sweden
CollaboratorOTHER_GOV
Luleå Tekniska Universitet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
SF-3612 months follow-upQuestionnaire, 36 questions ref Ware, 2000 version 2

Secondary

MeasureTime frameDescription
Bloodpressure12 months follow-up
Blood lipids12 months follow-up
Bodyweight12 months follow-up
HbA1c (for patients with type-2D) Blood pressure for patient with heart disease12 months follow-upHbA1c 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.
Alcohol consumption12 months follow-up
SOC-1312 months follow-upSOC-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-5D12 monts follow-upEQ5D (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.
Smoking habits12 months follow-up

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026