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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04398472




Registration number
NCT04398472
Ethics application status
Date submitted
4/03/2020
Date registered
21/05/2020

Titles & IDs
Public title
Evaluation of the Nextdoor KIND Challenge
Scientific title
Evaluation of the Nextdoor KIND Challenge
Secondary ID [1] 0 0
ND01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Loneliness 0 0
Social Isolation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - KIND Challenge

Active comparator: Challenge - Participants in the challenge will be asked to complete four activities over the next four weeks to address loneliness and social isolation in their communities.

The activities will involve doing an activity with people in their neighbourhood. These activities have been selected based on being positive, engaging and feasible to the average individuals. An example of the type of activities is having a conversation with a neighbour on the phone or via video chat and safely checking in on someone who is elderly or living alone. All activities will adhere to the relevant country or states health department's safety recommendations and laws during COVID-19.

Hypothesis 1 (H1). There will be a reduction in the primary outcome, loneliness in participants assigned to the Nextdoor KIND Challenge groups compared to the waitlist control group post the 4-week intervention

No intervention: Waitlist -


BEHAVIORAL: KIND Challenge
The KIND challenge consists of nominating an activity to complete over a 4 week period. The activities involve doing an activity with others in your neighbourhood. These activities are positive, engaging and feasible to the average individual. Activities adhere to relevant country or state department health and safety guidelines. For example; having a chat with a neighbour online, or bringing in rubbish bins for an elderly neighbour.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in loneliness as measured by UCLA Loneliness Scale - Version 3 (UCLA-LS; Russell, 1996).
Timepoint [1] 0 0
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 times points: baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Secondary outcome [1] 0 0
Change in quality of life as measured by European Health Interview Survey-Quality Of Life - 8-Item Index (EUROHIS-QOL-8; Power, 2003; Schmidt, Mühlan, & Power, 2005).
Timepoint [1] 0 0
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Secondary outcome [2] 0 0
Change in depression as measured by Patient Health Questionnaire-8 (PHQ-8; Kroenke & Spitzer, 2002).
Timepoint [2] 0 0
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Secondary outcome [3] 0 0
Change in social anxiety as measured by Mini-Social Phobia Inventory (Mini-SPIN; Connor, Kobak, Churchill, Katzelnick, & Davidson, 2001).
Timepoint [3] 0 0
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Secondary outcome [4] 0 0
Change in perceived stress as measured by Perceived Stress Scale-4 (PSS-4; Cohen, Williamson, Spacapan, & Oskamp, 1988).
Timepoint [4] 0 0
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Secondary outcome [5] 0 0
Change in positive and negative affect as measured by The Positive and Negative Affect Schedule-Short Form (PANAS-SF 10 item; Watson, Clark, & Tellegen, 1988)
Timepoint [5] 0 0
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Secondary outcome [6] 0 0
Change in social cohesion and community trust as measured by the Social Capital Scale (Martin, Rogers, Cook, & Joseph, 2004).
Timepoint [6] 0 0
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Secondary outcome [7] 0 0
Neighbourhood perception of change
Timepoint [7] 0 0
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Secondary outcome [8] 0 0
Neighbourhood importance
Timepoint [8] 0 0
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Secondary outcome [9] 0 0
Neighbourhood modified Social Relationship Index
Timepoint [9] 0 0
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Secondary outcome [10] 0 0
Neighbourhood conflict
Timepoint [10] 0 0
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Secondary outcome [11] 0 0
Neighbourhood number of contacts
Timepoint [11] 0 0
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Secondary outcome [12] 0 0
Acceptability
Timepoint [12] 0 0
4 weeks for challenge condition, 8 weeks for waitlist
Secondary outcome [13] 0 0
Feasibility of the Challenge
Timepoint [13] 0 0
4 weeks for challenge condition, 8 weeks for waitlist
Secondary outcome [14] 0 0
Change in social isolation risk as measured by Lubben Social Network Scale (LSNS; Lubben & Gironda, 2003).
Timepoint [14] 0 0
Challenge: 3 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, Waitlist: 4 data points - baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Secondary outcome [15] 0 0
Safety of the KIND Challenge
Timepoint [15] 0 0
Challenge: 4 weeks from baseline Waitlist: 8 weeks from baseline

Eligibility
Key inclusion criteria
* Community dwellers who use the Nextdoor platform.
* Aged 18 to 90 years old.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Individual's without proficient English reading comprehension skills will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2021
Sample size
Target
Accrual to date
Final
4500
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Swinburne University of Technology - Hawthorn
Recruitment postcode(s) [1] 0 0
- Hawthorn

Funding & Sponsors
Primary sponsor type
Other
Name
Swinburne University of Technology
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Brigham Young University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Sydney
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Manchester
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04398472