NCT03178305

Brief Summary

The Do CHANGE service is designed for cardiac patients who could benefit from lifestyle change and a better disease management. The study aims to support patients with behavior change by providing them with devices and behavioral intervention in order to facilitate long-term behavior change.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
2 countries

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

May 31, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 27, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

May 31, 2017

Last Update Submit

July 25, 2018

Conditions

Cardiovascular DiseasesLife StyleQuality of Life

Outcome Measures

Primary Outcomes (3)

  • Lifestyle

    Lifestyle change will be measured with the HPLP-II questionnaire which assesses multiple domains of lifestyle. This will make it possible to compare the two groups.

    3 months

  • Quality of Life (QoL)

    Quality of life will be assessed with the WHOQoL-Bref which is a validated questionnaire and taps into different domains of quality of life.

    3 months

  • Behavioral flexibility

    With the Do Something Different purpose designed questionnaire changes in behavioral flexibility will be measured. This programme has previously shown to be effective in changing lifestyle behaviors among physically healthy subjects.

    3 months

Secondary Outcomes (3)

  • Satisfaction, usability, and acceptance of the intervention

    6 months

  • Cost effectiveness

    6 months

  • Health care utilization

    6 months

Other Outcomes (2)

  • Identification of Subgroups that benefit

    6 months

  • Effects of intervention on physiological data

    6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Besides the behavior change programme (Do Something Different) 1. All patients will receive: Fitbit, Beddit, Care-portal, Do CHANGE app (including dietary habits picture taking), CookiT (smart spatula that monitors cooking behavior) 2. patients with heart failure will, in addition to the above mentioned, be offered a weight scale, blood pressure monitor, and FluiT (smart cup to measure fluid intake). 3. Patients with hypertension will also be offered a bloodpressure monitor. Data from these devices will be gathered and visible for patients (in patient portal) and for their health care provider (health care provider portal). In case of negative results the patient will be contacted by their health care provider (usually the cardiologist). Once every week the patients will be contacted to discuss their progress and will be given feedback about their dietary intake.

Behavioral: Do CHANGE

Care as usual

NO INTERVENTION

Patients in this arm will receive care as usual with no restrictions.

Interventions

Do CHANGEBEHAVIORAL

Besides the behavior change programme (Do Something Different) 1. All patients will receive: Fitbit, Beddit, Care-portal, Do CHANGE app (including dietary habits picture taking), CookiT (smart spatula that monitors cooking behavior) 2. patients with heart failure will, in addition to the above mentioned, be offered a weight scale, blood pressure monitor, and FluiT (smart cup to measure fluid intake). 3. Patients with hypertension will also be offered a bloodpressure monitor. Data from these devices will be gathered and visible for patients (in patient portal) and for their health care provider (health care provider portal). In case of negative results the patient will be contacted by their health care provider (usually the cardiologist). Once every week the patients will be contacted to discuss their progress and will be given feedback about their dietary intake.

Also known as: Do Something Different
Intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18-75 years
  • diagnosed with CAD, HF or HT
  • having at least two of the following risk factors: smoking, positive family history, increased cholesterol, diabetes, sedentary lifestyle, psychosocial risk factors.
  • Patients should also have access to the Internet and have a smartphone (and sufficient knowledge on using personal computer or smartphone)
  • sufficient knowledge of the countries' native language.

You may not qualify if:

  • significant cognitive impairments (e.g. dementia)
  • patients who are on the waiting list for heart transplantation
  • life expectancy \<1 year
  • life threatening comorbidities (e.g. cancers),
  • a history of psychiatric illness other than anxiety/depression
  • patients who do not have access to internet
  • patients with insufficient knowledge of the local pilot language (Dutch, Chinese and Catalonian).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Badalona Serveis Assisstencials

Badalona, Barcelona, 08911, Spain

Location

Buddhist Tzu Chi Dalin general hospital

Dalin, 62247, Taiwan

Location

Related Publications (7)

  • Roovers T, Habibovic M, Lodder P, Widdershoven JW, Kop WJ. Changes in heart rate variability during an eHealth behavior change intervention program in patients with cardiovascular disease. Int J Cardiol Heart Vasc. 2024 Nov 22;55:101563. doi: 10.1016/j.ijcha.2024.101563. eCollection 2024 Dec.

    PMID: 39649024DERIVED

  • Habibovic M, Piera-Jimenez J, Wetzels M, Widdershoven JWGM, Soedamah-Muthu SS. Associations between behavioral flexibility and health behavior in cardiac patients in the Do CHANGE trials. Health Psychol. 2022 Oct;41(10):710-718. doi: 10.1037/hea0001151. Epub 2022 May 16.

    PMID: 35575702DERIVED

  • Piera-Jimenez J, Winters M, Broers E, Valero-Bover D, Habibovic M, Widdershoven JWMG, Folkvord F, Lupianez-Villanueva F. Changing the Health Behavior of Patients With Cardiovascular Disease Through an Electronic Health Intervention in Three Different Countries: Cost-Effectiveness Study in the Do Cardiac Health: Advanced New Generation Ecosystem (Do CHANGE) 2 Randomized Controlled Trial. J Med Internet Res. 2020 Jul 28;22(7):e17351. doi: 10.2196/17351.

    PMID: 32720908DERIVED

  • Habibovic M, Gavidia G, Broers E, Wetzels M, Ayoola I, Ribas V, Piera-Jimenez J, Widdershoven J, Denollet J. Type D personality and global positioning system tracked social behavior in patients with cardiovascular disease. Health Psychol. 2020 Aug;39(8):711-720. doi: 10.1037/hea0000823. Epub 2020 Apr 16.

    PMID: 32297772DERIVED

  • Broers ER, Widdershoven J, Denollet J, Lodder P, Kop WJ, Wetzels M, Ayoola I, Piera-Jimenez J, Habibovic M; Do CHANGE Consortium. Personalized eHealth Program for Life-style Change: Results From the "Do Cardiac Health Advanced New Generated Ecosystem (Do CHANGE 2)" Randomized Controlled Trial. Psychosom Med. 2020 May;82(4):409-419. doi: 10.1097/PSY.0000000000000802.

    PMID: 32176191DERIVED

  • Broers ER, Gavidia G, Wetzels M, Ribas V, Ayoola I, Piera-Jimenez J, Widdershoven JWMG, Habibovic M; Do CHANGE consortium. Usefulness of a Lifestyle Intervention in Patients With Cardiovascular Disease. Am J Cardiol. 2020 Feb 1;125(3):370-375. doi: 10.1016/j.amjcard.2019.10.041. Epub 2019 Nov 6.

    PMID: 31761149DERIVED

  • Habibovic M, Broers E, Piera-Jimenez J, Wetzels M, Ayoola I, Denollet J, Widdershoven J. Enhancing Lifestyle Change in Cardiac Patients Through the Do CHANGE System ("Do Cardiac Health: Advanced New Generation Ecosystem"): Randomized Controlled Trial Protocol. JMIR Res Protoc. 2018 Feb 8;7(2):e40. doi: 10.2196/resprot.8406.

    PMID: 29422454DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Jos Widdershoven, MD, PhD

    Elisabeth-TweeSteden Ziekenhuis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled trial where patients will be randomly (2:2) assigned to the intervention vs control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

May 31, 2017

First Posted

June 6, 2017

Study Start

July 27, 2017

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

July 26, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)ES(1)