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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04398472
Ethics application status
Date submitted
4/03/2020
Date registered
21/05/2020
Date last updated
23/04/2021

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
Behaviour - 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 -


Behaviour: 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
Behaviour
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). - The UCLA-LS is a 20-item measure employing a 1 (Never) to 4 (Always) Likert-type scale. The measure consists of both positively- and negatively-worded items that assess loneliness (e.g., How often do you feel that you are no longer close to anyone?). The UCLA-LS has been shown to correlate negatively with life satisfaction and perceived social support, thus supporting its convergent validity with related constructs. The range of possible scores is from 0-80 where higher scores indicate higher levels of loneliness.
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). - The EUROHIS-QOL-8 is an 8-item measure of quality of life consisting of questions that assess overall QOL, general health, energy, daily living activity, self-esteem, social relationships, finances and home. The measure is derived from the WHOQOL-BREF and shares a similar 5-point Likert-scale response format. The scale has demonstrated good qualities in term of internal consistency (Cronbach's alpha = 0.83) and satisfactory convergent and discriminant validity (Schmidt et al., 2005). The range of possible scores is 8-40 where higher scores indicate higher quality of life.
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). - The PHQ-8 is an 8-item measure of depression severity based on 8 of the 9 item criteria of the DSM-IV. The measure was derived from the PHQ-9 however; the ninth question was omitted from this study as depression was not a primary outcome. Depression severity is scored based on the presence of depressive symptomology in the previous 2 weeks of measure admission. The scale uses a 1 (not at all) to 4 (nearly every day) Likert scale with higher scores indicating higher levels of depressive symptomology. The range of possible scores is 8-32. The PHQ-9 has been shown to have good criterion and construct validity and excellent internal consistency (Kroenke, Spitzer, & Williams, 2001). The PHQ-8 shares similar properties in terms of validity and reliability and is therefore an adequate alternative to its 9-item scale counterpart (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). - The Mini-SPIN is a brief 3-item measure of generalised social anxiety disorder. The measure employs a 5-point Likert scale form 1 (not at all) to 5 (extremely), with higher scores indicating a greater level of generalised social anxiety. The range of possible scores is 3-15. The Mini-SPIN has shown high sensitivity in detecting social anxiety disorder (Connor et al., 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). - This four-item measure of stress was derived from the original 14-item Perceived Stress Scale (PSS). This measure consists of both positively and negatively worded items that asses an individual's evaluation of stressful events. The measure employs a 5-point Likert scale ranging from 0 (never) to 4 (very often). The range of possible scores is 0-16 where higher scores indicate higher levels of perceived stress. The PSS-4 has been shown to negatively correlate with levels of perceived health, social support, being male, and older age (Warttig, Forshaw, South, & White, 2013). The scale has demonstrated fair reliability and adequate psychometric properties (Warttig et al., 2013).
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) - The PANAS-SF is a 10-item short form version of the Positive and Negative Affect Scale scale. The measure asks respondents to rate the extent to which they feel a particular emotion along a 5-point Likert scale ranging from 1 (very slightly) to 5 (extremely). The range of possible scores is 5-25 for each subscale (positive affect and negative affect) where higher scores indicate higher levels of positive or negative affect. This subscale measure has been shown to have high levels of internal consistency (Watson et al., 1988) and acceptable levels of convergent validity (Roesch, 1998).
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). - The Social Capital Scale is a 7-item measure designed to assess social cohesion and trust in a community. The scale was derived from a similar scale used in Sampson, Raudenbush, and Earls (1997). This measure consists of both positively and negatively worded items and is recorded on a 2 point Likert scale ranging form 0 (strongly disagree or disagree) to 1 (strongly Agree or agree). The range of possible scores is 0-14 where higher scores indicate higher levels of social cohesion and trust. This measure was shown to be a reliable tool to measure social cohesion and trust at a neighbourhood level (Sampson et al., 1997).
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 - This question asks if participants thought their neighbourhood was improving from 1 (improving) to 3 (declining).
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 - This question asks how important participants thought it was to know their neighbours from 1 (very important) to 5 (very important)
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 - The 3-item scale was modified from the Social Relationship Index (34). Three factors measuring support, ambivalence, and aversive. We ask how participants feel towards their neighbours when needing advice, understanding, or a favour - helpfulness, upsetting, mixed/conflicted feelings on a Likert scale from 1 (not at all) to 6 (extremely).
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 - Participants will be asked to reflect on their interactions with their neighbours in the past month using a dichotomous yes/no to the following: absence/presence of neighbour conflict, critical comments towards the participant, participant critical of neighbours.
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 - This item asks the number of people the participants knows in their neighbourhood, 0 (0-5 neighbours) to 4 (15+ neighbours).
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 - We measured acceptability around these factors, including how connected (1 not at all connected to 10 very connected), how meaningful was the activity (1 not very meaningful to 10 very meaningful), how safe they felt when completing the challenge (1 not very safe to 10 very safe), how positive they felt (1 not very positive to 10 very positive), how comfortable they felt doing the activity (1 not at all comfortable to 10 very comfortable). It is anticipated that the Nextdoor KIND challenge will yield ratings of more than 5 indicating higher levels of acceptability across these outcomes.
Timepoint [12] 0 0
4 weeks for challenge condition, 8 weeks for waitlist
Secondary outcome [13] 0 0
Feasibility of the Challenge - Feasibility will be assessed by a high retention rate (i.e., <40% drop-out).
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). - The LSNS is an 18-item scale that assesses the frequency and quality of contact - such as talking about private matters - in an individual's network. There are three subscales and each consists of 6 items relating to family, neighbour and friend connections. The scale employs a 0 (none) to 5 (nine or more) Likert scale and includes 6 items (eg. How many relatives do you see or hear from at least once a month?). Higher scores indicate larger social networks and lower risk of social isolation. The scale has demonstrated adequate levels of reliability and the proposed clinical cut-points showed good convergent validity (Lubben & Gironda, 2003). The range of possible scores is from 0-90 where higher scores indicate more social connections and lower risk of social isolation.
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 - We assess for unintended harms (e.g., conflict) during this period. In this case, we measure the occurrence of neighbour conflict with a single dichotomous item, 'Did you have a conflict with a neighbour because of the KIND challenge'. This item is measured with a yes or no response.
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
Gender
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
Not Applicable
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
There is ample evidence showing that loneliness is a public health problem that influences
social, mental and physical health. The current project is about evaluating the effectiveness
of the Kindness Is NextDoor (KIND) Challenge, a social networking platform aimed at reducing
loneliness and social isolation in specific Nextdoor communities within Australia. As the
landscape through which people make social connections changes due to technology it is
important to evaluate the effectiveness of platforms that are designed to reduce loneliness
within communities. This is the first study of its kind in Australia and will help provide
insight into how to target social isolation and loneliness within communities using social
networking platforms.
Trial website
https://clinicaltrials.gov/show/NCT04398472
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

Summary results
Other publications