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The Feasibility of Make My Day-A Randomized Controlled Pilot Trial of a Stroke Prevention Program in Primary Healthcare.

ABSTRACT: Incorporating and sustaining engaging everyday activities (EEAs) in everyday life holds potential for improving health and wellbeing; thus, there is reason to explore EEAs as a behavioral change technique in stroke prevention. The aim of this study was to evaluate the feasibility of the stroke prevention program Make My Day (MMD) for people with moderate-to-high risk for stroke in a primary healthcare setting, where EEAs are utilized to promote healthy activity patterns. A randomized controlled pilot trial was designed to evaluate the feasibility of MMD. Twenty-nine persons at risk for stroke were recruited and randomized into either an intervention group (n = 14) receiving MMD or a control group (n = 15) receiving brief health advice and support with goal setting. The results suggest that MMD is feasible, with timely recruitment, overall high response rates and study completion, and sensitivity to change in key outcome measures. Moreover, the results demonstrate that the application of EEAs can be useful for promoting behavioral change in stroke prevention. Recommendations for improvements for a full-scale trial include recruiting a relevant sample, using reliability- and validity-tested outcome measures, and implementing strategies to limit missing data.

SUBMITTER: Malstam E

PROVIDER: S-EPMC10572257 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

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The Feasibility of Make My Day-A Randomized Controlled Pilot Trial of a Stroke Prevention Program in Primary Healthcare.

Mälstam Emelie E Asaba Eric E Åkesson Elisabet E Guidetti Susanne S Patomella Ann-Helen AH

International journal of environmental research and public health 20230925 19

Incorporating and sustaining engaging everyday activities (EEAs) in everyday life holds potential for improving health and wellbeing; thus, there is reason to explore EEAs as a behavioral change technique in stroke prevention. The aim of this study was to evaluate the feasibility of the stroke prevention program Make My Day (MMD) for people with moderate-to-high risk for stroke in a primary healthcare setting, where EEAs are utilized to promote healthy activity patterns. A randomized controlled ...[more]

PMID: 37835098

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Project description:BackgroundThe prevalence of alcohol use disorder (AUD) among women in South Korea has been rising, causing public health problems. Yet women's treatment needs are mostly unmet in South Korea due to the lack of women-focused treatment programs. This study evaluated the feasibility, acceptability, and clinical outcomes of a therapeutic community (TC)-oriented day treatment program for Korean women with AUD on alcohol abstinence self-efficacy, forgiveness, and spirituality.MethodsThe current study employed a quasi-experimental, non-equivalent control group design with a pretest and posttest. Participants were assigned to 6-month TC-oriented day treatment program (n = 19) or usual treatment (n = 21). Feasibility (treatment completion rate) and acceptability (overall program satisfaction) were assessed. Alcohol abstinence was measured as a clinical outcome at baseline, 3 months, and 6 months. Repeated measures using Alcohol Abstinence Self-Efficacy (AASE), Enright Forgiveness Inventory-Korea (EFI-K), and Spiritual Assessment Scale (SAS) were also obtained from both conditions at those three time points.ResultsFifteen participants (78.9%) in the intervention group successfully completed the program. The overall program satisfaction ratings were very high (4.9 ± 0.2). Continuous abstinence rates at 6 months were significantly higher in the treatment group (78.9%) than in the control group (9.5%). Results of the two-way repeated measures ANOVA indicated that statistically significant two-way (group × time) interaction effects were found for the intervention group on AASE, EFI-K, and SAS but not for the control group on any of the outcomes.ConclusionThe current study demonstrated the feasibility and acceptability of implementing a TC-oriented intensive day treatment program to promote recovery in Korean women with AUD. This intervention merits further investigation as a potential strategy to help address alcohol abstinence self-efficacy, forgiveness and spirituality.Trial registrationKCT0006386 (Cris.nih.go.kr).

Project description:INTRODUCTION:Stroke is a globally common disease that has detrimental effects on the individual and, more broadly, on society. Lifestyle change can contribute to reducing risk factors for stroke. Although a healthy lifestyle has direct benefits, sustaining and incorporating healthy activities into everyday life is a challenge. Engaging everyday activities have the potential to support lifestyle change and to promote sustainable activity patterns. Current healthcare is failing to reduce modifiable risk factors in people at risk, and in addition to current practice, there is a need for systematic and efficient non-pharmacological and non-surgical stroke-prevention strategies. The aim of the pilot study was to increase knowledge about the effects of a prevention programme and its feasibility to promote sustainable and healthy activity patterns among persons at risk of stroke. METHODS AND ANALYSIS:The proposed pilot study will be a two-armed randomised, assessor-blinded, parallel pilot trial. The study will include feasibility data, investigating acceptability and delivery of the intervention. Persons at risk of stroke (n=60) will be included in a mobile phone-supported prevention programme. The 10-week programme will be conducted at primary healthcare clinics, combining group meetings and online resources to support self-management of lifestyle change. Main outcomes are stroke risk, lifestyle habits and healthy activity patterns. Assessments will be performed at baseline and at follow-up (immediately following the end of the programme and at 6 and 12 months). Effects of the programme will be analysed using inferential statistics. Feasibility will be analysed using both qualitative and quantitative methods. ETHICS AND DISSEMINATION:The study has been approved by the Regional Ethical Review Board in Stockholm, Sweden, being granted reference numbers 2015/834-31, 2016/2203-32 and 2019/01444. Study results will be disseminated through peer-review journals and presentations to mixed audiences at regional and international conferences. TRIAL REGISTRATION NUMBER:NCT03730701.

Dataset Information

The Feasibility of Make My Day-A Randomized Controlled Pilot Trial of a Stroke Prevention Program in Primary Healthcare.

Publications

The Feasibility of Make My Day-A Randomized Controlled Pilot Trial of a Stroke Prevention Program in Primary Healthcare.

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