NCT05109026

Brief Summary

This is an anonymous needs assessment survey of the population of an Irish urban town. We plan to collect anonymous survey data in order to better understand residents needs and to determine the desired functionality of a new coach-led wellness app operated by our partners. This platform is currently trialled for health care professionals working in the RCSI Hospital Group. The survey will collect information on participants demographics, their lifestyle (including sleep, exercise, food, relationships, meaning and purpose, substance use and stress management). We will also ask participants about their use of wellness apps to support healthy choices related to their lifestyle. We also plan to conduct a qualitative assessment to further explore needs related to lifestyle health in specific cohorts, namely, older people (65 years and older), recent migrants, members of the travelling community, perinatal women, lone-parents, individuals with physical disabilities, secondary school students and remote workers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 5, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

September 5, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

October 26, 2021

Last Update Submit

October 13, 2023

Conditions

Keywords

SurveyInterviewsNeeds Assessment

Outcome Measures

Primary Outcomes (3)

  • Needs assessment survey

    An anonymous needs assessment survey (online and hard copies) will be conducted.

    January 2022-February 2022

  • Needs assessment interivews

    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.

    January 2022-March 2022

  • Analysis

    Analysis of summary anonymous aggregate data will be used to inform future stages of this research.

    March 2022- April 2022

Study Arms (8)

Older people

Members of the population aged 65 years and older.

Recent migrants

Members of the population who are recent migrants to the community.

Members of the travelling community

Members of the population who are members of the travelling community.

Perinatal women.

Members of the population who are pregnant or within a year of giving birth.

Lone-parents

Members of the population who are raising children alone.

Individuals with physical disabilities

Members of the population who have a physical disability.

Secondary school students

Members of the population attending secondary school.

Remote workers

Members of the population currently working from home.

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • \- Participants will be members of the urban town being studied.

You may not qualify if:

  • \- Non a member of the urban town being studied.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Positive Healthy Sciences

Dublin, Ireland

Location

Related Publications (9)

  • 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.

    PMID: 31329872BACKGROUND
  • 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.

    PMID: 32716520BACKGROUND
  • 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.

    PMID: 33207689BACKGROUND
  • 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.

    PMID: 32504808BACKGROUND
  • 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.

    PMID: 33634520BACKGROUND
  • 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.

    PMID: 32562349BACKGROUND
  • 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.

    PMID: 31929010BACKGROUND
  • 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.

    PMID: 27091846BACKGROUND
  • 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.

    PMID: 32683689BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 26, 2021

First Posted

November 5, 2021

Study Start

September 5, 2022

Primary Completion

January 30, 2023

Study Completion

January 30, 2023

Last Updated

October 16, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Only summary aggregate data will be shared.

Locations