Clinical trial NCT06197347: Web-based Nursing Intervention to Promote Physical Activity Among Older Adults With Coronary Heart Disease
Official title: Web-based Nursing Intervention to Promote Physical Activity Among Older Adults With Coronary Heart Disease: Protocol for a Mixed Method Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Older Adults
Web-based Intervention
Nursing
Healthy Lifestyle Habits
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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. 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.

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:

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Physical activity level by the self-reported questionnaire "Electronic diary of physical activity".
timeFrame: Pre-intervention and immediately after the intervention.
Secondary outcomes:
measure: Motivation level by the digital analog scale "Motivation scale" from 1 to 10.
timeFrame: Pre-intervention and immediately after the intervention.
measure: Self-efficacy level by the digital analog scale "Self-efficacy level" from 1 to 10.
timeFrame: Pre-intervention and immediately after the intervention.
measure: Level of knowledge by a 5-questions multiple-choice quiz that measures knowledge of physical activity and coronary heart disease
timeFrame: Pre-intervention and immediately after the intervention.
measure: Quality of life level by the SF-36 questionnaire
timeFrame: Pre-intervention and immediately after the intervention.
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre hospitalier de l'Univerité de Montréal
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Véronique Dubé, PhD
role: STUDY_DIRECTOR
References: