NCT06197347

Brief Summary

The purpose of this study is to develop and evaluate a web-based nursing intervention aimed at increasing physical activity in people aged 65 years and older with coronary heart disease. This study aims to answer the following questions:

  1. 1.What are the needs of older adults living with coronary heart disease in terms of a web-based nursing intervention to help them increase their level of physical activity?
  2. 2.What is the acceptability (content, structure, usefulness) and feasibility (recruitment, retention, adherence, fidelity) of a web-based nursing intervention to support older adults living with coronary heart disease as they increase their level of physical activity?
  3. 3.What are the preliminary effects of the web-based nursing intervention on the physical activity level and quality of life of older adults living with coronary heart disease?
  4. 4.What are the qualitative impacts of the web-based nursing intervention as perceived by older adults on their physical activity level, quality of life, motivation, knowledge and self-efficacy?
  5. 5.How can the preliminary effects of a web-based nursing intervention, developed in response to the needs of older adults living with coronary heart disease, be illustrated by its impacts as perceived by older adults post-intervention?

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

September 29, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

September 29, 2023

Last Update Submit

November 27, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Physical activity level by the self-reported questionnaire "Electronic diary of physical activity".

    Self-reported questionnaire that measures the amount of physical activity performed each week in minutes.

    Pre-intervention and immediately after the intervention.

Secondary Outcomes (4)

  • Motivation level by the digital analog scale "Motivation scale" from 1 to 10.

    Pre-intervention and immediately after the intervention.

  • Self-efficacy level by the digital analog scale "Self-efficacy level" from 1 to 10.

    Pre-intervention and immediately after the intervention.

  • Level of knowledge by a 5-questions multiple-choice quiz that measures knowledge of physical activity and coronary heart disease

    Pre-intervention and immediately after the intervention.

  • Quality of life level by the SF-36 questionnaire

    Pre-intervention and immediately after the intervention.

Study Arms (1)

Web-based nursing intervention

EXPERIMENTAL

Web-based intervention (8 sessions weekly) which includes the support of a nurse that aims to increase physical activity and quality of life for older people living with heart disease, as well as enhancing knowledge, motivation and self-efficacy.

Behavioral: Web-based nursing intervention : Ch@ngeons Ensemble

Interventions

The web-based nursing intervention, named "Ch@ngeons Ensemble," was designed to increase physical activity and quality of life among older adults living with CHD. The intervention will be multicomponent, including educational content, videos, forums, goal planning, an electronic physical activity journal, and virtual written interactions with a nurse. An initial in-person meeting with the nurse will be provided to foster the older adult's commitment to the intervention and help build a relationship of trust. Throughout the intervention, the nurse will asynchronously provide counseling, feedback, and encouragement, and attempt to promote quality of life, knowledge, motivation, and self-efficacy among the older adults.

Web-based nursing intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • aged 65 years or older
  • agreement to participate in the study about 3 months post-hospitalization for a coronary bypass graft surgery or a percutaneous coronary intervention (as motivation to change behavior would be highest during this period)
  • no concurrent involvement in an intervention designed to increase their level of physical activity (e.g., a cardiac rehabilitation program, consultation with physical activity expert) during their participation in the project
  • an interest in increasing their level of physical activity post-hospitalization
  • fluency in French, spoken and written
  • living in the greater Montreal area
  • access to a computer connected to the Internet
  • no cognitive impairments according to the patient record (i.e., decreased or impaired complex attention, executive functions, learning abilities, memory or social skills)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier de l'Univerité de Montréal

Montreal, Quebec, Canada

RECRUITING

Related Publications (1)

  • Lavoie A, Dube V. Web-Based Nursing Intervention to Promote Physical Activity Among Older Adults After Coronary Revascularization: Protocol for Mixed Method Pilot Study. JMIR Res Protoc. 2025 May 21;14:e67678. doi: 10.2196/67678.

Study Officials

  • Véronique Dubé, PhD

    Centre hospitalier de l'Université de Montréal (CHUM)

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2023

First Posted

January 9, 2024

Study Start

June 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

November 29, 2024

Record last verified: 2024-11

Locations