Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06197347 |
Other study ID # |
2024-11810 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 2024 |
Est. completion date |
December 2024 |
Study information
Verified date |
January 2024 |
Source |
Centre hospitalier de l'Université de Montréal (CHUM) |
Contact |
Audrey Lavoie, PhD (c) |
Phone |
514-890-8000 |
Email |
audrey.lavoie.chum[@]ssss.gouv.qc.ca |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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. 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. 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. 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. 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. 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.
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:
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. 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. 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. 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. 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.