- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06197347
Web-based Nursing Intervention to Promote Physical Activity Among Older Adults With Coronary Heart Disease
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:
- 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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Audrey Lavoie, PhD (c)
- Phone Number: 31591 514-890-8000
- Email: audrey.lavoie.chum@ssss.gouv.qc.ca
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada
- Recruiting
- Centre hospitalier de l'Univerité de Montréal
-
Contact:
- Audrey Lavoie, PhD candidate
- Phone Number: 31591 514-890-8000
- Email: audrey.lavoie.7@umontreal.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Web-based nursing intervention
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Pre-intervention and immediately after the intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motivation level by the digital analog scale "Motivation scale" from 1 to 10.
Time Frame: Pre-intervention and immediately after the intervention.
|
Digital analog scale from 1 to 10 to measure motivation levels. 1 = low motivation level, 10 = high motivation level.
|
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.
|
Digital analog scale from 1 to 10 to measure self-efficacy levels 1 = low self-efficacy level, 10 = high self-efficacy level.
|
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.
|
Quiz on physical activity and coronary heart disease.
High score = high level of knowledge.
|
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.
|
SF-36 questionnaire.
High score = a more favorable health state.
|
Pre-intervention and immediately after the intervention.
|
Collaborators and Investigators
Investigators
- Study Director: Véronique Dubé, PhD, Centre hospitalier de l'Université de Montréal (CHUM)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-11810
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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