Evaluation of a Preparatory eHealth Intervention to Support Cardiac Patients During Their Waiting Period.

NCT05698121 | Completed

• 1 other identifier: NL81969.078.22
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this pilot study is to evaluate the feasibility of an eHealth intervention for cardiac patients during their waiting period before their rehabilitation. The main questions it aims to answer are:

• What is the feasibility of an eHealth intervention designed for cardiac patients with a low socio-economic position during the waiting period before their cardiac rehabilitation.
• What is the potential effect of this intervention on patient activation and feelings of certainty and guidance. Participants will:
• Be randomised in either intervention or control group
• Fill in a questionnaire at the start of their waiting period (after release from the hospital)
• Use the eHealth intervention during their waiting period (usually 2 to 6 weeks)(intervention group only)
• Fill in a questionnaire at the start of their rehabilitation Researchers will compare intervention and control group to see if the intervention has improved patient activation and feelings of certainty and guidance.

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (3)

• Acceptability of the intervention

  Acceptability will be measured using a self-designed questionnaire (9 items) based on the USE questionnaire.

  During the entire waiting period (usually 2 to 6 weeks)

• Use of the intervention

  Use will be determined based on the number of days used, length of use (period from first to last day use), number of viewed messages and time spent per visit.

  During the entire waiting period (usually 2 to 6 weeks)

• Experience of the intervention

  Experience will be determined based on a thematic analysis of several qualitative semi-structured interviews.

  During the entire waiting period (usually 2 to 6 weeks)

Secondary Outcomes (2)

• Patient activation

  During the entire waiting period (usually 2 to 6 weeks)

• Guidance and certainty

  During the entire waiting period (usually 2 to 6 weeks)

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group will use an eHealth application during the waiting period before cardiac rehabilitation starts.

Device: CapriXpress

Control

NO INTERVENTION

The control group will go through the usual waiting period before the start of cardiac rehabilitation.

Interventions

CapriXpress DEVICE

The app is a digital, tailored intervention aimed at activating patients during their waiting period between discharge from hospital and start of their cardiac rehabilitation by providing certainty and guidance. The goal of the intervention is to reach the end-goal: the start of the rehabilitation. Progression towards this end-goal is made automatically as time advances. The intervention provides guidance by providing the patient with a set of daily messages. These messages are pre-made by representatives of different disciplines within cardiac rehabilitation. The messages contain discipline-related information and suggestions as well as a perspective on peer experiences. Each day, the patient is free to choose which and the number of messages to engage with.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is eligible for participation in cardiac rehabilitation
• The patient has signed the standard rehabilitation agreement provided by the rehabilitation centre and has agreed to be contacted for research purposes
• The patient is aged 18 years or above
• The patient signs an informed consent form
• The patient is sufficient in the Dutch language
• The patient has access to a mobile phone with internet
• The patient is identified as someone with a low SEP, which will be determined by the socioeconomic status of the neighbourhood

You may not qualify if:

• Upon referral, the medical status of the patient is screened by a physician of the CR center. Patients with severe physical, psychological, or cognitive impairments will not be included in the study.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (2)

Capri Hartrevalidatie

Rotterdam, South Holland, 3062 MA, Netherlands

Location

Capri Hartrevalidatie

The Hague, South Holland, Netherlands

Location

Related Publications (1)

• Faber JS, Kraal JJ, Ter Hoeve N, Al-Dhahir I, Breeman LD, Chavannes NH, Evers AWM, Bussmann HBJ, Visch VT, van den Berg-Emons RJG. An eHealth intervention for patients with a low socioeconomic position during their waiting period preceding cardiac rehabilitation: a randomized feasibility study. Eur Heart J Digit Health. 2024 Nov 14;6(1):115-125. doi: 10.1093/ehjdh/ztae084. eCollection 2025 Jan.

  PMID: 39846066 DERIVED

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Rita van den Berg-Emons

  Erasmus Medical Center

  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: Principal Investigator

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 26, 2023
• Study Start: February 8, 2023
• Primary Completion: July 23, 2023
• Study Completion: July 23, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)