Clinical Trials Directory

Trials / Completed

CompletedNCT05279508

Make My Day - a Stroke Prevention Program

Make My Day: an eHealth Supported Stroke Prevention Program for Primary Health Care Preventing Stroke and Supporting Everyday Activities

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
122 (actual)
Sponsor
Karolinska Institutet · Academic / Other
Sex
All
Age
55 Years – 75 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to evaluate the effects of a person-centered stroke prevention program implemented in primary healthcare. It is a primary prevention program aiming to reduce stroke risk and thereby prevent stroke through the enabling of lifestyle changes by introducing health beneficial engaging everyday activities promoting healthy activities and habits.

Detailed description

This study is a single-blind randomized control trial with the aim to evaluate the effects of a stroke prevention program, Make My Day (MMD), in comparison to ordinary primary healthcare services for people at risk for stroke. The MMD prevention program aims to reduce modifiable stroke risk factors and the future risk of stroke by introducing health beneficial engaging everyday activities enabling lifestyle changes and promoting healthy activity patterns and habits. It also includes a mHealth application consisting of six domains for registering daily activities, experiences and behaviours: Goal achievements, Physical activity, Engaging everyday activities, Tobacco and alcohol use, Stress levels and Dietary habits, to increase health literacy and awareness of current habits and to foster self-management. Engaging everyday activities (EEA´s) are activities the person perceives as valuable, meaningful, and purposeful, as well as provide positive feelings and a sense of participation. EEA´s are performed regularly and are a part of a person's life and depending on the activity it may or may not contribute to health. The MMD prevention program is person-centered group interventio with health professionals as interventionists. The program starts with an individual meeting at baseline with a lifestyle analysis that includes formulating individual activity goals. Follow-up assessment is done one week after the last group session. There are 6 group sessions where each session has a pre-set theme e.g. stroke risk, engaging everyday activities, physical activity, diet, life habits and routines. Five group-sessions will be conducted over a five week period with a booster session after another five weeks, in total 10 weeks. The MMD prevention program is a theoretically grounded, complex intervention developed in accordance with the Medical Research Council (MRC) guidelines for developing complex interventions. And in line with the MRC guidelines a feasibility and pilot study have already been conducted. To enable reduction of stroke risk and achieve healthy lifestyle habits the MMD program uses strategies based on behavioural change theories. Behaviour change derives from the interaction process between the person, the environment, and the action. Key in the MMD-program is the incorporation of health beneficial EEA´s, either to incorporate new health beneficial EEA´s or to alter current non health beneficial EEA´s.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMake My Day - stroke prevention programA stroke prevention program within primary healthcare

Timeline

Start date
2022-04-09
Primary completion
2024-04-17
Completion
2024-05-08
First posted
2022-03-15
Last updated
2024-07-01

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT05279508. Inclusion in this directory is not an endorsement.