Older AdultsNCT06197347
Web-based Nursing Intervention to Promote Physical Activity Among Older Adults With Coronary Heart Disease
A study testing Web-based nursing intervention : Ch@ngeons Ensemble in people with Older Adults and Web-based Intervention, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Older Adults, Web-based Intervention, Nursing
- What is being tested?
- Web-based nursing intervention : Ch@ngeons Ensemble
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre hospitalier de l'Univerité de Montréal
Montreal, Quebec
Audrey Lavoie, PhD candidate, 514-890-8000 ext. 31591, audrey.lavoie.7@umontreal.ca
About this study
Official title: Web-based Nursing Intervention to Promote Physical Activity Among Older Adults With Coronary Heart Disease: Protocol for a Mixed Method Pilot Study
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:
Read more
- 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?
- 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?
- 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?
- 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?
- 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?
A web-based nursing intervention was developed based on the needs of seniors living with coronary heart disease. 30 older adults living with heart disease will take part in the 8-week intervention. The effects of the intervention will be evaluated on the physical activity level, quality of life, knowledge, motivation and self-efficacy of older adults.
Read the detailed description
Introduction: Given the high prevalence of coronary heart disease among older adults and the aging of populations, there is a need for secondary prevention interventions to help older adults become more physically active. Web-based interventions could be considered for this purpose, knowing that Internet use is growing rapidly among older adults. In addition, since older adults would appreciate developing a trusting relationship with a healthcare professional, such as a nurse, web-based interventions should include this support, which is not widely observed in the literature.
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:
- 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?
- 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?
- 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?
- 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?
- 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?
Method: This study will be conducted in two phases. Phase 1 will focus on developing the intervention according to the Intervention Mapping framework, in collaboration with a team of healthcare professionals and based on the needs of older adults. In Phase 2, we will evaluate the intervention through a pilot study with a sequential explanatory design. First, a single group pre-post test will be used to assess the intervention's preliminary effects on physical activity (electronic questionnaire), quality of life (SF-36 questionnaire), knowledge (quiz), motivation and self-efficacy (visual analog scale) of 30 older adults living with coronary heart disease, as well as the feasibility of the intervention. Second, a descriptive qualitative design will employ semi-structured interviews to assess the impacts of the intervention as perceived by 8 to 12 older adults who participated in the intervention, as well as its acceptability. Non-parametric statistics and a thematic analysis will be produced. Lastly, a joint display will be used to integrate mixed data.
Discussion: The results of this study will provide insight into the development and preliminary evaluation of a web-based nursing intervention to support older adults living with coronary heart disease as they increase their physical activity levels.
- Being tested
- Web-based nursing intervention : Ch@ngeons Ensemble
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based nursing intervention : Ch@ngeons EnsembleBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Web-based nursing intervention : Ch@ngeons Ensemble |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-intervention and immediately after the intervention.
Secondary outcomes (4)
Motivation level by the digital analog scale "Motivation scale" from 1 to 10.
Digital analog scale from 1 to 10 to measure motivation levels. 1 = low motivation level, 10 = high motivation level.
Measured: Pre-intervention and immediately after the intervention.
Self-efficacy level by the digital analog scale "Self-efficacy level" from 1 to 10.
Digital analog scale from 1 to 10 to measure self-efficacy levels 1 = low self-efficacy level, 10 = high self-efficacy level.
Measured: 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
Quiz on physical activity and coronary heart disease. High score = high level of knowledge.
Measured: Pre-intervention and immediately after the intervention.
Quality of life level by the SF-36 questionnaire
SF-36 questionnaire. High score = a more favorable health state.
Measured: Pre-intervention and immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start1 Jun 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique Dubé, PhD, Study director, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197347
- Sponsor's protocol ID
- 2024-11810
- Status last verified
- Nov 2024
- First submitted
- 29 Sep 2023
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lavoie A, Dube V. Supporting Physical Activity and Quality of Life in Older Adults with Coronary Heart Disease: Development of a Web-Based Nursing Intervention. Can J Nurs Res. 2026 Sep;58(3):329-343. doi: 10.1177/08445621261452849. Epub 2026 May 26.
PubMed 42187195Lavoie 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.
PubMed 40397502
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Nursing Intervention to Promote Physical Activity Among Older Adults With Coronary Heart Disease: Protocol for a Mixed Method Pilot Study
- ClinicalTrials.gov ID
- NCT06197347
- Acronym / sponsor ID
- 2024-11810
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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?
- 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?
- 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?
- 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?
A web-based nursing intervention was developed based on the needs of seniors living with coronary heart disease. 30 older adults living with heart disease will take part in the 8-week intervention. The effects of the intervention will be evaluated on the physical activity level, quality of life, knowledge, motivation and self-efficacy of older adults.
Detailed description
Introduction: Given the high prevalence of coronary heart disease among older adults and the aging of populations, there is a need for secondary prevention interventions to help older adults become more physically active. Web-based interventions could be considered for this purpose, knowing that Internet use is growing rapidly among older adults. In addition, since older adults would appreciate developing a trusting relationship with a healthcare professional, such as a nurse, web-based interventions should include this support, which is not widely observed in the literature.
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:
- 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?
- 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?
- 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?
- 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?
- 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?
Method: This study will be conducted in two phases. Phase 1 will focus on developing the intervention according to the Intervention Mapping framework, in collaboration with a team of healthcare professionals and based on the needs of older adults. In Phase 2, we will evaluate the intervention through a pilot study with a sequential explanatory design. First, a single group pre-post test will be used to assess the intervention's preliminary effects on physical activity (electronic questionnaire), quality of life (SF-36 questionnaire), knowledge (quiz), motivation and self-efficacy (visual analog scale) of 30 older adults living with coronary heart disease, as well as the feasibility of the intervention. Second, a descriptive qualitative design will employ semi-structured interviews to assess the impacts of the intervention as perceived by 8 to 12 older adults who participated in the intervention, as well as its acceptability. Non-parametric statistics and a thematic analysis will be produced. Lastly, a joint display will be used to integrate mixed data.
Discussion: The results of this study will provide insight into the development and preliminary evaluation of a web-based nursing intervention to support older adults living with coronary heart disease as they increase their physical activity levels.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Web-based nursing intervention | Experimental | Behavioral: Web-based nursing intervention : Ch@ngeons EnsembleWeb-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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based nursing intervention : Ch@ngeons EnsembleThe 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. | Behavioural | Web-based nursing intervention |
Primary outcome
Physical activity level by the self-reported questionnaire "Electronic diary of physical activity".
Time frame: Pre-intervention and immediately after the intervention.
Self-reported questionnaire that measures the amount of physical activity performed each week in minutes.
4 secondary outcomes
Motivation level by the digital analog scale "Motivation scale" from 1 to 10.
Time frame: Pre-intervention and immediately after the intervention.
Self-efficacy level by the digital analog scale "Self-efficacy level" from 1 to 10.
Time frame: 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
Time frame: Pre-intervention and immediately after the intervention.
Quality of life level by the SF-36 questionnaire
Time frame: Pre-intervention and immediately after the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Derived from this study: PubMed 42187195Lavoie A, Dube V. Supporting Physical Activity and Quality of Life in Older Adults with Coronary Heart Disease: Development of a Web-Based Nursing Intervention. Can J Nurs Res. 2026 Sep;58(3):329-343. doi: 10.1177/08445621261452849. Epub 2026 May 26.
- Derived from this study: PubMed 40397502Lavoie 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Véronique Dubé, PhD study director
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based nursing intervention : Ch@ngeons Ensemble in people with Older Adults and Web-based Intervention, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site 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 8 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Audrey Lavoie, PhD (c) (514-890-8000 ext. 31591, audrey.lavoie.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity level by the self-reported questionnaire "Electronic diary of physical activity". (time frame: Pre-intervention and immediately after the intervention.). 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 NCT06197347, which also lists 2 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 29 Nov 2024.