NCT06616935

Brief Summary

The goal of this feasibility study is to find out if routine referrals of older adults aged 65years and over to community activities provided by third sector organisations will reduce their loneliness risk. Researcher will compare referrals of older adults to community activities following reablement provided by intermediate care to attendance of online activities to find out which will be effective in reducing loneliness risk of older adults aged 65years and over. Researcher will also find out if it will be feasible to complete a full randomised controlled trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

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

September 24, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

November 24, 2025

Status Verified

September 1, 2024

Enrollment Period

10 months

First QC Date

September 24, 2024

Last Update Submit

November 18, 2025

Conditions

Keywords

LonelinessOlder AdultsReablementIntermediate Care

Outcome Measures

Primary Outcomes (3)

  • Risk of loneliness of participants as identified with the De Jon Gierveld (DJG)loneliness scale.

    Quantitative measure of loneliness risk from 0 (no risk) to 11(highest risk) with the DJG scale with a score of at least 3 representing being at risk of loneliness for the current study.

    Enrollment where the initial measures will be taken and then at six months from when the initial measures were taken which will be the end of the study.

  • Frailty of participants as measured by the Frailty Index Scale.

    The Frailty Index Scale quantifies function between 1 and 9 with one being the least frail and 9 being very frail. This will help establish whether the intervention improves function in participants.

    Initial Frailty Index scale will be measured when participants are randomised to intervention groups and the final Frailty Index Scale will be measured six months from being assigned to intervention group.

  • Self reported physical activity levels and mental wellbeing of participants as identified by EQ-5D-5L scale.

    The EQ-5D-5L scale is a self reported outcome measure which allows participants to assess their own physical function, mental wellbeing and health. This will help establish whether the interventions improve the reported physical function, mental wellbeing and health of participants or not.

    EQ-5D-5L will initially be collected when participants are randomised to intervention groups and again at six months from when they were randomised to intervention groups.

Secondary Outcomes (3)

  • Feasibility Outcomes

    Six months from enrolment where the outcome measures will be initially collected.

  • Suitability of randomising participants as measured by the percentage of participants who will be able to attend their assigned interventions for the six month duration

    The feasibility of randomising participants will be determined at six months from when participants were randomised to intervention groups.

  • Feasibility of delivering the interventions within the time stipulated as identified by the percentage of participants completing their assigned interventions at six months from initial randomisation of participants.

    The feasibility of delivering the interventions within the time stipulated will be determined at six months from the time of initial randomisation of participants to intervention groups.

Study Arms (2)

Routine referrals to community activities

OTHER

Routine referrals to community activities following receiving reablement and being discharged without further action. Intervention group 1 referrals to community activities.

Other: Intervention group one, community activities.

Online exercises and activity

OTHER

Online exercises and activity group.

Other: Intervention group two

Interventions

Intervention group one: participants will have a list of free activities in the community provided by third sector organisations to choose from. Participants will be referred to their chosen activities and expected to attend for six months. Intervention group two: Participants will attend weekly online exercises and activities led by the researcher.

Routine referrals to community activities

Online exercises and activities

Online exercises and activity

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Past and current patients of the team aged 65years and over retrieved from 12months up to the month of recruitment (August 2023 to September 2024).
  • Patients who have had at least three hospital admissions and three admissions to the team.
  • Patients whose admissions resulted or will result in being discharged with no further action.
  • Patients identified as at loneliness risk by a score of 3 or more on the De Jon Loneliness Scale.

You may not qualify if:

  • Patients of the team who will be discharged with planned care package or family support.
  • Patients of the team who lack mental capacity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intermediate Care Team

Kettering, Northamptonshire, NN16 8TD, United Kingdom

Location

Related Publications (8)

  • Gierveld, J. D. J., & Tilburg, T. V. (2006). A 6-item scale for overall, emotional, and social loneliness: Confirmatory tests on survey data. Research on aging, 28(5), 582-598.

    BACKGROUND
  • Findlay, R. A. (2003). Interventions to reduce social isolation amongst older people: where is the evidence? Ageing & Society, 23(5), 647-658.

    BACKGROUND
  • Clegg A, Bates C, Young J, Ryan R, Nichols L, Ann Teale E, Mohammed MA, Parry J, Marshall T. Development and validation of an electronic frailty index using routine primary care electronic health record data. Age Ageing. 2016 May;45(3):353-60. doi: 10.1093/ageing/afw039. Epub 2016 Mar 3.

    PMID: 26944937BACKGROUND
  • Bartlett H., Warburton J., Lui C.-W., Peach L. & Carroll M. (2013). Preventing social isolation in later life: findings and insights from a pilot Queensland intervention study. Ageing & Society 33 (7), 1167-1189.

    BACKGROUND
  • Bowling, A., (2014). Research methods in health: investigating health and health services. McGraw-hill education (UK).

    BACKGROUND
  • Braun, V. Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3 (2). pp. 77-101. ISSN 1478-0887 Available from: http://eprints.uwe.ac.uk/11735

    BACKGROUND
  • Aspinal F, Glasby J, Rostgaard T, Tuntland H, Westendorp RG. New horizons: Reablement - supporting older people towards independence. Age Ageing. 2016 Sep;45(5):572-6. doi: 10.1093/ageing/afw094. Epub 2016 May 21.

    PMID: 27209329BACKGROUND
  • Age UK (2012) Day care services for elderly "hit by cuts". Reported by BBC news on 12th December 2012. bbc.co.uk/news/uk-20855819 Accessed on 28/06/2017.

    BACKGROUND

Study Officials

  • Jacqueline Parkes, Professor

    University of Northampton Faculty of Health, Education & Society

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Intervention one: community activities. Intervention two: online exercises and activities.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2024

First Posted

September 27, 2024

Study Start

November 1, 2024

Primary Completion

August 20, 2025

Study Completion

August 30, 2025

Last Updated

November 24, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

This will be considered later.

Locations