NCT01478672

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
741

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
Last Updated

November 23, 2011

Status Verified

November 1, 2011

Enrollment Period

5 months

First QC Date

November 2, 2011

Last Update Submit

November 21, 2011

Conditions

DiabetesHeart DiseaseQuality of Life

Keywords

Promotion health

Outcome Measures

Primary Outcomes (1)

  • SF-36

    Questionnaire, 36 questions ref Ware, 2000 version 2

    12 months follow-up

Secondary Outcomes (8)

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

    12 months follow-up

  • Bloodpressure

    12 months follow-up

  • Blood lipids

    12 months follow-up

  • Bodyweight

    12 months follow-up

  • Smoking habits

    12 months follow-up

  • +3 more secondary outcomes

Study Arms (2)

Standard care

NO INTERVENTION

Health coaching and and Life-long Monitoring

EXPERIMENTAL
Procedure: Health Coaching and Life-long Monitoring

Interventions

Health Coaching and Life-long MonitoringPROCEDURE

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

Health coaching and and Life-long Monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luleå University of Technology

Luleå, 971 87, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 30291058DERIVED

Related Links

MeSH Terms

Conditions

Diabetes MellitusHeart Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

November 2, 2011

First Posted

November 23, 2011

Study Start

March 1, 2011

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

November 23, 2011

Record last verified: 2011-11

Locations

SE(1)