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Heart FailureCHF-CePPORTNCT01864369

Canadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure: CHF-CePPORT

A study of Heart Failure, run by University Health Network, Toronto at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Chronic Heart Failure (CHF) is a growing public health issue in Canada. Hospital re-admission within 1-year after diagnosis is 25-40%, and the 5-year rate of CHF death is 50%. Counseling by multidisciplinary health care teams helps CHF patients to improve self-care behaviors (for medications, diet, exercise, smoking… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
248 participants
Where
3 sitesCanada
Study dates
Sep 2013to Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female patients 18 years of age who are diagnosed with heart failure with reduced ejection fraction ("systolic HF") corresponding to New York Heart Association Class II-III for 3 months prior to enrolment;
  • documentation of LVEF 40%;
  • subject has access to a personal computer;

Who cannot join

  • Documentation at enrolment of renal failure, significant liver disease or poorly controlled diabetes mellitus;
  • persistent systolic or diastolic hypertension [systolic > 170 mmHg or diastolic > 100 mmHg despite antihypertensive therapy;
  • CHF secondary to cardiovascular co-morbidities/procedures;
  • previous heart transplant or wait listed for heart transplant at time of enrolment

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • University Health Network

    Toronto, Ontario, M5G 2N2

  • St.Paul's Hospital- UBC

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

About this study

Chronic Heart Failure (CHF) is a growing public health issue in Canada. Hospital re-admission within 1-year after diagnosis is 25-40%, and the 5-year rate of CHF death is 50%. Counseling by multidisciplinary health care teams helps CHF patients to improve self-care behaviors (for medications, diet, exercise, smoking cessation and symptom monitoring), and this reduces the rate of death and CHF hospitalization. In the absence of intervention, patient adherence to these behaviors is below recommended standards and quality of life among CHF patients becomes progressively compromised. A major challenge is to make self-care counseling available without overtaxing health care resources.

This year multicenter clinical trial will establish and evaluate a Canadian e-platform that provides multidisciplinary e-counseling to help patients with CHF to initiate and maintain recommended self-care behaviors. The investigators will recruit 298 CHF patients in Toronto, Montreal and Vancouver. The investigators hypothesize that a 12-month program of e-Counseling + Usual Care versus general eInfo + Usual Care will improve quality of life, self-care behaviors, program engagement, and heart health. This proposal is based upon previous clinical trials in CHF, e-health and preventive lifestyle counseling by our team. The novel contribution of this research is that it will establish an infrastructure for a pan-Canadian e-platform in preventive e-counseling for CHF. A key feature of this proposal is that our multidisciplinary team will work with professional heart health organizations to share our findings and e-health resources with the public and other health care professionals in Canada, which will help to galvanize research and clinical work in eCounseling. Our clinical trial will strengthen eCounseling services in order to improve the quality of life of patients with CHF.

Conditions
Heart Failure
Being tested
eCounseling + Usual Care
Keywords
Heart Failure, e-counseling, quality of life, self-care
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • eCounseling + Usual CareBehavioural

    This intervention will use film vignettes and interactive web pages. The e-counseling messages will promote: (i) validation of the subject's stage of "readiness" for behavior change, (ii) collaborative participation by means of subject-selected menus, (iii) reinforcement of "change talk" to resolve ambivalence, (iv) use of self-help information and e-tools for self-monitoring of targeted self-care behaviors, and (v) development of cognitive-behavioral skills to build and strengthen efficacy. Messages will be proactively sent to Controls according to the following schedule: weekly for months 1 to 4, bi-weekly for months 5 to 8, and monthly for months 9 to 12.

Study groups in NCT01864369
Study groupRoleWhat they receive
Control: eInfo + Usual CareActive comparatorUsual Care + eInfo on general guidelines for heart healthy living
Receives: Behavioral: eCounseling + Usual Care
Behavioral: eCounseling + Usual CareExperimentalBehavioral:eCounseling + Usual Care: interactive web pages utilized to provide e-counseling messages and e-tools.
Receives: Behavioral: eCounseling + Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of Life: Kansas City Cardiomyopathy Questionnaire

    The primary outcome in CHF-CePPORT is quality of life, as measured by the number of subjects who demonstrate a clinically meaningful increase of ≥5 points on the summary index of the Kansas City Cardiomyopathy Questionnaire (KCCQ).

    Measured: 12 months

Secondary outcomes (8)

  1. Program engagement and usability

    Active engagement with digital platform: total time, # logons, % material accessed

    Measured: 4- and 12- months

  2. Behavioral,functional and clinical outcomes

    Quality of life: number of subjects with KCCQ ≥5 points

    Measured: 4- and 12- months

  3. Behavioral, clinical and funcitonal outcomes

    Adherence to daily dietary guidelines for fruit and vegetable intake: NIH/NCI Diet History Questionnaire.

    Measured: 4 and 12- months

  4. Behavioral, functional and clinical outcomes

    Physical activity: 4-day step count with Triaxial Accelerometer.

    Measured: 4- and 12- months

  5. Behavioral, functional and clinical outcomes

    Self-reported daily activity: The Physical Activity Scale for the Elderly.

    Measured: 4- and 12- months

  6. Behavioral, functional and clinical outcomes

    Psychological adjustment: Patient Health Questionnaire - 9-item scale (Depression)

    Measured: 4- and 12- months

  7. Clinical and functional assesments.

    Functional capacity: 6-minute walk test.

    Measured: 12-months

  8. Behavioral, functional and clinical outcomes

    Patient Health Questionnaire: PHQ-9 (Depression) and GAD-7 (Anxiety)

    Measured: 4- and 12- months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionJan 2018
  4. Study completionJul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01864369
Sponsor's protocol ID
MOP 126118
Acronym
CHF-CePPORT
Status last verified
Jun 2021
First submitted
15 May 2013
Last updated
6 Jul 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Nolan RP, Syed F, Stogios N, Maunder R, Sockalingam S, Tai ES, Cobain M, Peiris RG, Huszti E. The evaluation of goal-directed activities to promote well-being and health in heart failure: EUROIA scale. J Patient Rep Outcomes. 2024 Apr 29;8(1):47. doi: 10.1186/s41687-024-00723-x.

    PubMed 38683439

  • Nolan RP, Ross HJ, Farkouh ME, Huszti E, Chan S, Toma M, D'Antono B, White M, Thomas S, Barr SI, Perreault S, McDonald M, Zieroth S, Isaac D, Wielgosz A, Mielniczuk LM. Automated E-Counseling for Chronic Heart Failure: CHF-CePPORT Trial. Circ Heart Fail. 2021 Jan;14(1):e007073. doi: 10.1161/CIRCHEARTFAILURE.120.007073. Epub 2021 Jan 19.

    PubMed 33464959

  • Nolan RP, Payne AY, Ross H, White M, D'Antono B, Chan S, Barr SI, Gwadry-Sridhar F, Nigam A, Perreault S, Farkouh M, McDonald M, Goodman J, Thomas S, Zieroth S, Isaac D, Oh P, Rajda M, Chen M, Eysenbach G, Liu S, Zbib A. An Internet-Based Counseling Intervention With Email Reminders that Promotes Self-Care in Adults With Chronic Heart Failure: Randomized Controlled Trial Protocol. JMIR Res Protoc. 2014 Jan 30;3(1):e5. doi: 10.2196/resprot.2957.

    PubMed 24480783

Questions about this trial

What is this clinical trial studying?

A study of Heart Failure, run by University Health Network, Toronto at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life: Kansas City Cardiomyopathy Questionnaire (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01864369, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2021.

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