Make my Day - Primary Prevention of Stroke

NCT03730701 | Completed DMC

• 1 other identifier: MMDPrev1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the feasibility of a digital, person-centered stroke prevention program with a focus on primary prevention. The program is aiming to enable lifestyle change and to promote healthy activity patterns to decrease risk factors for stroke and in that way prevent future stroke.

Conditions

Non-Communicable Diseases; Stroke; Cardiovascular Risk Factor

Keywords

Life style; Primary prevention; Modifiable risk factors; mHealth; Engaging occupation

Outcome Measures

Primary Outcomes (4)

• Stroke risk score card

  Through the stroke risk score card estimate change in risk for Stroke and how high this risk are. Three colums with different colours. Red, yellow and green. Red is High risk, Yellow is Caution, and Green is Low risk. In total there is 8 points per column. High risk: \>3 red points: Ask about stroke prevention right away. Caution: 4-6: A good start. Work on reducing risk. Low risk: 6-8: You're doing very well at controlling stroke risk.

  Baseline, within a month after the intervention, 1 year follow-up after baseline.

• Healthy Activity patterns (PPR profile)

  PPRP (Daily Experiences of Pleasure, Productivity, and Restoration Profile) is a activity-diary where change is meant to be measured regarding activity patterns in everyday life. Experiences are scored as 1-7 in four domains (Pleasure, Productivity, Restoration and Health promotion). For example the domain of health promotion is scored as 1 (very unhealthy) to 7 (very healthy) in regards to different engagements in everyday life. The higher the value the better.

  Baseline, within a month after the intervention, 1 year follow-up after baseline.

• Questions of Lifestyle habits

  Measuring change in lifestyle habits with a self-percieved questionnaire with open questions and estimations of different lifestyle habits in everyday life regarding dietary, smoking, alcohol, physical activity habits. Participants selects an option on each question or writes an estimated number or answer on what and how they usually do regarding each lifestyle habit. For example if they are or have been smoking and how much. Example of answers options: 1. I have never smoked 2. I have smoked but I have stoped 3. I smoke, but not daily 4. I smoke daily.....X cigarettes a day. Where answer 4. is worse than answer 1. And on alcohol consumption. Question: How many standard glases do you drink a normal week? Answer with a self-percieved number, no fixed response options.

  Baseline, within a month after the intervention, 1 year follow-up after baseline.

• Canadian Occupational Performance Measurement (COPM)

  COPM is a client-centered, semi-structured interview assessment that enables the person to identify and prioritize areas of improvement in everyday life. To support goal-setting, defined areas is scored between 0-10 guiding prioritizations of areas of which is scored in regards to performance and satisfaction, also scored between 0-10. Where a higher value is better experience of performance and satisfaction of occupations. Mean change will be measured.

  Baseline, within a month after the intervention, 1 year follow-up after baseline.

Secondary Outcomes (6)

• Weight

  Baseline, within a month after the intervention, 1 year follow-up after baseline.

• Blood pressure

  Baseline, within a month after the intervention, 1 year follow-up after baseline.

• Occupational Balance (OBQ4)

  Baseline, within a month after the intervention, 1 year follow-up after baseline.

• Motivation for lifestyle changes

  Baseline, within a month after the intervention, 1 year follow-up after baseline.

• Lisat-11

  Baseline, within a month after the intervention, 1 year follow-up after baseline.

Study Arms (2)

Prevention treatment group

EXPERIMENTAL

Prevention program with 10 week blended intervention utilizing both a digital health app, group-sessions with peers and a interprofessional team of health-care workers chairing 5+1 themed group-sessions as support to change lifestyle habits in to a pattern of activities (behaviors and actions) in everyday life that can promote health and wellbeing and decrease risk for stroke. Lifestyle analysis and stroke risk screening before, at follow up and 12 months after the prevention program.

Behavioral: Prevention program for stroke

Standard treatment group

NO INTERVENTION

Usal care in Swedish primary health care. In addition a Lifestyle analysis and stroke risk screening before, at follow up and 12 months after the prevention program.

Interventions

Prevention program for stroke BEHAVIORAL

The prevention program include individual and group intervention sessions supported by a digital platform. The program will be personally tailored in relation to what the person needs and what to change and the individuals rediness for change. The digital platform will support the person during and in between sessions by prompting goals and goal-fulfilment, logging activities, step counts and provide a forum for sharing and reflection.

Prevention treatment group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons with increased risk for stroke according to Stroke risk score card
• Persons motivated for participating in an intense digital lifestyle prevention (including the use of a mobile phone with the function to download and use apps),

You may not qualify if:

• Persons having had a stroke or TIA
• Persons with a diagnosis of dementia or cognitive impairment
• Drug abuse

Sponsors & Collaborators

• Emelie Malstam: lead
• University of Gavle: collaborator

Study Sites (1)

Karolinska Institutet

Huddinge, Stockholm County, 14183, Sweden

Location

Related Publications (1)

• Patomella AH, Guidetti S, Malstam E, Eriksson C, Bergstrom A, Akesson E, Kottorp A, Asaba E. Primary prevention of stroke: randomised controlled pilot trial protocol on engaging everyday activities promoting health. BMJ Open. 2019 Nov 2;9(11):e031984. doi: 10.1136/bmjopen-2019-031984.

  PMID: 31678952 DERIVED

MeSH Terms

Conditions

Noncommunicable Diseases; Stroke

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ann-Helen Patomella, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Doctoral candidate

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: November 5, 2018
• Study Start: August 6, 2019
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2020
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)