- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05109026
Connect-5 Needs Assessment Survey to Identify Healthy Lifestyle Requirements of a Rural Irish Community (CONNECT-5)
Connect-5 Needs Assessment to Identify Requirements of a Rural Irish Community Related to a an Online Digital Platform Solution, Designed to Change Behaviour, Related to Lifestyle Medicine and Mental Health.
Study Overview
Status
Conditions
Detailed Description
There has been an increase in lifestyle related diseases worldwide. Living a healthy lifestyle is important to prevent lifestyle-related diseases such as heart disease, obesity, diabetes, mental health issues, certain cancers, autoimmunity and gastro-intestinal disease. The economic impact of these lifestyle-related diseases in Europe alone is set to exceed €200 billion by 2030. Worldwide, one in five people are at an increased risk of developing severe COVID-19, mostly as a result of underlying lifestyle-related diseases. Additionally, global efforts to manage COVID-19 infection have disrupted regular care required by those with these issues. Dealing with this requires that people better manage their own health and address lifestyle related factors that increase the risk associated with such diseases, including inactivity, substance abuse and unhealthy diet. These risk factors are modifiable and can be reduced by health interventions and tools to support a healthy lifestyle.
The COVID-19 pandemic caused prolonged feelings of fear, uncertainty and isolation among the general population. This is likely to impact vulnerable members of society, such as young people, elderly people and those in ethnic minority communities in greater proportions. Children and adolescents are experiencing increased adverse mental health effects such as social isolation, loneliness, depression and anxiety, during the Covid-19 pandemic. Irish adults aged 70 and over have reported worse mental health and increased feelings of loneliness due to cocooning throughout the pandemic. This social isolation and loneliness puts them at increased risk of cognitive and cardiovascular decline. It is important that we prioritise the development of strategies to maintain social engagement, manage loneliness and encourage continued physical activity among older people.
Work habits are currently changing at a rapid pace. Significant sections of our workforces are now working from home and at least 50% are expected to remain at home, even after the current pandemic has resolved. Reports indicate that a significant proportion of this workforce is experiencing issues with disconnection and mental health. As a result, understanding the impact of remote and flexible working arrangements on employee health and mental wellbeing has been included as a research priority within psychological science. While there is evidence that remote working has positive effects on well-being, these effects are not consistent. Remote working may also lead to greater levels of professional isolation, reduced work-life balance, increase work-related fatigue and have negative impacts on well-being. This study is being conducted to better understand citizen's needs in relation to living a healthier lifestyle.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Dublin, Ireland
- Centre for Positive Healthy Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
We aim to collect survey data from at least 1,820 participants (20% response rate).
We will conduct interviews with up to 5 members of each target cohort from the community ( older people, recent migrants, members of the travelling community, perinatal women, lone-parents, individuals with physical disabilities, and remote workers).
Description
Inclusion Criteria:
- Participants will be members of the urban town being studied.
Exclusion Criteria:
- Non a member of the urban town being studied.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Older people
Members of the population aged 65 years and older.
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Recent migrants
Members of the population who are recent migrants to the community.
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Members of the travelling community
Members of the population who are members of the travelling community.
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Perinatal women.
Members of the population who are pregnant or within a year of giving birth.
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Lone-parents
Members of the population who are raising children alone.
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Individuals with physical disabilities
Members of the population who have a physical disability.
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Secondary school students
Members of the population attending secondary school.
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Remote workers
Members of the population currently working from home.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Needs assessment survey
Time Frame: January 2022-February 2022
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An anonymous needs assessment survey (online and hard copies) will be conducted.
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January 2022-February 2022
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Needs assessment interivews
Time Frame: January 2022-March 2022
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Anonymous qualitative interviews will be conducted in conjunction with community liaison officers, over the telephone with up to 5 members of the following target groups - older people (65 years and older), recent migrants, members of the travelling community, perinatal women, lone-parents, individuals with physical disabilities, and remote workers.
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January 2022-March 2022
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Analysis
Time Frame: March 2022- April 2022
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Analysis of summary anonymous aggregate data will be used to inform future stages of this research.
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March 2022- April 2022
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Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Ng R, Sutradhar R, Yao Z, Wodchis WP, Rosella LC. Smoking, drinking, diet and physical activity-modifiable lifestyle risk factors and their associations with age to first chronic disease. Int J Epidemiol. 2020 Feb 1;49(1):113-130. doi: 10.1093/ije/dyz078.
- Hyland P, Shevlin M, McBride O, Murphy J, Karatzias T, Bentall RP, Martinez A, Vallieres F. Anxiety and depression in the Republic of Ireland during the COVID-19 pandemic. Acta Psychiatr Scand. 2020 Sep;142(3):249-256. doi: 10.1111/acps.13219. Epub 2020 Aug 9.
- Nearchou F, Flinn C, Niland R, Subramaniam SS, Hennessy E. Exploring the Impact of COVID-19 on Mental Health Outcomes in Children and Adolescents: A Systematic Review. Int J Environ Res Public Health. 2020 Nov 16;17(22):8479. doi: 10.3390/ijerph17228479.
- Loades ME, Chatburn E, Higson-Sweeney N, Reynolds S, Shafran R, Brigden A, Linney C, McManus MN, Borwick C, Crawley E. Rapid Systematic Review: The Impact of Social Isolation and Loneliness on the Mental Health of Children and Adolescents in the Context of COVID-19. J Am Acad Child Adolesc Psychiatry. 2020 Nov;59(11):1218-1239.e3. doi: 10.1016/j.jaac.2020.05.009. Epub 2020 Jun 3.
- Bailey T, Hastings RP, Totsika V. COVID-19 impact on psychological outcomes of parents, siblings and children with intellectual disability: longitudinal before and during lockdown design. J Intellect Disabil Res. 2021 May;65(5):397-404. doi: 10.1111/jir.12818. Epub 2021 Feb 25.
- O'Connor DB, Aggleton JP, Chakrabarti B, Cooper CL, Creswell C, Dunsmuir S, Fiske ST, Gathercole S, Gough B, Ireland JL, Jones MV, Jowett A, Kagan C, Karanika-Murray M, Kaye LK, Kumari V, Lewandowsky S, Lightman S, Malpass D, Meins E, Morgan BP, Morrison Coulthard LJ, Reicher SD, Schacter DL, Sherman SM, Simms V, Williams A, Wykes T, Armitage CJ. Research priorities for the COVID-19 pandemic and beyond: A call to action for psychological science. Br J Psychol. 2020 Nov;111(4):603-629. doi: 10.1111/bjop.12468. Epub 2020 Jul 19.
- Ward MP. SARS-CoV-2, where to now? Transbound Emerg Dis. 2020 Jul;67(4):1411-1413. doi: 10.1111/tbed.13654. Epub 2020 Jun 19. No abstract available.
- Fried L, Prohaska T, Burholt V, Burns A, Golden J, Hawkley L, Lawlor B, Leavey G, Lubben J, O'Sullivan R, Perissinotto C, van Tilburg T, Tully M, Victor C. A unified approach to loneliness. Lancet. 2020 Jan 11;395(10218):114. doi: 10.1016/S0140-6736(19)32533-4. No abstract available.
- Valtorta NK, Kanaan M, Gilbody S, Ronzi S, Hanratty B. Loneliness and social isolation as risk factors for coronary heart disease and stroke: systematic review and meta-analysis of longitudinal observational studies. Heart. 2016 Jul 1;102(13):1009-16. doi: 10.1136/heartjnl-2015-308790. Epub 2016 Apr 18.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Connect-5 Needs Assessment
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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