NCT01310491

Brief Summary

The purpose of this trial is to determine if by structured telephone based health coaching programme supported by remote monitoring system among type 2 diabetes, coronary artery disease and heart failure patients the investigators are able to improve their quality of life as measured by the SF-36 questionnaire and reduce a value of HbA1c under 6,5 % among those type 2 diabetes patients who had elevated value of HbA1c when recruited.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
595

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Feb 2011

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

February 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 17, 2014

Status Verified

February 1, 2014

Enrollment Period

1.8 years

First QC Date

March 7, 2011

Last Update Submit

February 14, 2014

Conditions

Type 2 DiabetesCoronary Artery DiseaseHeart FailureAtrial FibrillationOther Arrhythmias

Outcome Measures

Primary Outcomes (2)

  • Health related quality of life

    Health related quality of life is assessed by the SF-36 questionnaire.

    12 months

  • HbA1c change over time (participants with T2DM only)

    12 months

Secondary Outcomes (8)

  • Medication compliance

    12 months

  • Blood pressure reduction

    12 months

  • Weight reduction

    12 months

  • Activity increase

    12 months

  • Smoke cessation

    12 months

  • +3 more secondary outcomes

Study Arms (1)

Usual Care

NO INTERVENTION
Behavioral: Health coaching

Interventions

Health coachingBEHAVIORAL

Telephone based health coaching supported by tele-monitoring.

Usual Care

Eligibility Criteria

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

You may qualify if:

  • Age \> 18 years
  • Capability of filling in questionnaires in Finnish language.
  • Be able to use Remote Patient Monitoring System
  • Be able to use the devices provided
  • Has adequate cognitive capacities to participate
  • In their medical records, one or both of the following diagnoses:
  • a) Type 2 Diabetes, for enrolment
  • diagnosed over 3 months prior to the enrolment and
  • HbA1c \> 6,5 % b) Heart Disease, for enrolment
  • Ischemic heart disease or
  • Heart Failure or
  • Atrial fibrillation or
  • Other arrhythmia
  • Be able to walk

You may not qualify if:

  • Not willing to participate (e.g., not willing to sign the consent)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Etelä-Karjalan sosiaali- ja terveydenhuollon kuntayhtymä

Lappeenranta, 53100, Finland

Location

Related Publications (1)

  • Karhula T, Vuorinen AL, Raapysjarvi K, Pakanen M, Itkonen P, Tepponen M, Junno UM, Jokinen T, van Gils M, Lahteenmaki J, Kohtamaki K, Saranummi N. Telemonitoring and Mobile Phone-Based Health Coaching Among Finnish Diabetic and Heart Disease Patients: Randomized Controlled Trial. J Med Internet Res. 2015 Jun 17;17(6):e153. doi: 10.2196/jmir.4059.

    PMID: 26084979DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Coronary Artery DiseaseHeart FailureAtrial Fibrillation

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tuula Karhula, MD, PhD

    South Karelia social and health district

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Substitute Director of Elderly Services

Study Record Dates

First Submitted

March 7, 2011

First Posted

March 8, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 17, 2014

Record last verified: 2014-02

Locations

FI(1)