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Trial registered on ANZCTR


Registration number
ACTRN12623000127606
Ethics application status
Approved
Date submitted
22/12/2022
Date registered
7/02/2023
Date last updated
10/12/2023
Date data sharing statement initially provided
7/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The INTErGenerational intervention taRgeting fraIlTY trial (INTEGRITY)
Scientific title
The INTErGenerational intervention taRgeting fraIlTY trial (INTEGRITY): A randomised wait-list controlled trial in older adults and preschool children
Secondary ID [1] 308465 0
None
Universal Trial Number (UTN)
Trial acronym
INTEGRITY
Linked study record
This is a follow up study from our pilot trial conducted in 2022 ACTRN12622000368730.

Health condition
Health condition(s) or problem(s) studied:
Frailty 328560 0
Condition category
Condition code
Public Health 325576 325576 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of 20 weeks of intergenerational sessions with one 2-hour session a week with 10 older adults and 10 preschool children at each participating preschool. The 20 weeks are divided into 2 school terms (10 weeks each) with a 2 weeks school holidays/term break between the school terms.

The sessions are led by two preschool educators (at least one of whom must have an up-to-date accreditation in early child education at Diploma or Degree level) trained to deliver intergenerational content (the research team will provide training). A researcher or trained volunteer will also be present at each session to help advise and to help set up/clear away and monitor the room for safety issues – e.g., items on the floor that could cause a trip hazard.

The sessions are based within the Early Years Learning Framework and allow for adaptation to child and adult interests. Each week begins with a welcome song with associated actions and movement then 2 hours of themed activities that include at least 15 minutes of moderate activity in the first 10 weeks rising to 30 minutes in the last 10 weeks plus at least 15 minutes of light activity. The intensity of activity will be based on recommendation by physical activity expert from the research team (i.e. physiotherapist and exercise physiologist). Also included each week are tasks that require executive function, memory (recall and recognition), attention and language. Examples of cognitive tasks include, egg and spoon game and food memory game. Each physical or cognitive task will require older adult and child participation and can be adapted to suit different physical limitations or to stretch those who are more able. Examples of exercise and/or physical tasks modified captain's ball, balloon relay race and dancing. Each week must also contain tasks that require older adult and children collaboration and social engagement.

The researcher or trained volunteer who attended the session will play an active part in the reflection and support the preschool educators in planning the subsequent week. Session attendance of each participant will also be measured using the attedance list.
Intervention code [1] 325112 0
Prevention
Comparator / control treatment
The control group will be asked to continue with their usual activities and receive no intergenerational practice sessions during the research period. The control group will commence their intergenerational sessions in the same format as the intervention group after the follow up assessments have been completed (i.e., a waitlist control group).
Control group
Active

Outcomes
Primary outcome [1] 333421 0
Change in older adult frailty measured using the Frailty Index (FI)
Timepoint [1] 333421 0
At baseline and post-intervention (after at least 17 weeks of the intervention)
Secondary outcome [1] 417001 0
Older adults — Grip strength assessed using a Jamar dynamometer
Timepoint [1] 417001 0
At baseline and after at least 17 weeks of the intervention.
Secondary outcome [2] 417002 0
Older adults — Mobility, balance and strength measures (Composite outcome) using the Short Physical Performance Battery test
Timepoint [2] 417002 0
At baseline and after at least 17 weeks of the intervention.
Secondary outcome [3] 417003 0
Older adults - Balance assessed using the near tandem balance test
Timepoint [3] 417003 0
At baseline and after at least 17 weeks of the intervention.
Secondary outcome [4] 417004 0
Older adults - Mobility assessed using the Time Up and Go (TUG) test
Timepoint [4] 417004 0
At baseline and after at least 17 weeks of the intervention.
Secondary outcome [5] 417048 0
Older adults — Mood assessed using the Positive And Negative Affect Scale (PANAS)
Timepoint [5] 417048 0
Intervention group: At baseline, after at least 17 weeks of the intervention, and at 6 and 12 months post intervention.

Control group: At baseline and after at least 17 weeks of the intervention.
Secondary outcome [6] 417049 0
Older adults — Quality of life assessed using the Short Form 36 (SF-36)
Timepoint [6] 417049 0
Intervention group: At baseline, after at least 17 weeks of the intervention, and at 6 and 12 months post intervention.

Control group: At baseline and after at least 17 weeks of the intervention.
Secondary outcome [7] 417050 0
Older adults — Social engagement assessed using the Lubben Social Network Scale-6
Timepoint [7] 417050 0
Intervention group: At baseline, after at least 17 weeks of the intervention, and at 6 and 12 months post intervention.

Control group: At baseline and after at least 17 weeks of the intervention.
Secondary outcome [8] 417051 0
Older adults — Loneliness assessed using the UCLA loneliness scale
Timepoint [8] 417051 0
Intervention group: At baseline, after at least 17 weeks of the intervention, and at 6 and 12 months post intervention.

Control group: At baseline and after at least 17 weeks of the intervention.
Secondary outcome [9] 417052 0
Older adults — Concerns about falling assessed using the Iconographical Falls Efficacy Scale (IconFES)
Timepoint [9] 417052 0
Intervention group: At baseline, after at least 17 weeks of the intervention, and at 6 and 12 months post intervention.

Control group: At baseline and after at least 17 weeks of the intervention.
Secondary outcome [10] 417053 0
Older adults — Falls Health Literacy assessed using the Falls Health Literacy Scale
Timepoint [10] 417053 0
Intervention group: At baseline, after at least 17 weeks of the intervention, and at 6 and 12 months post intervention.

Control group: At baseline and after at least 17 weeks of the intervention.
Secondary outcome [11] 417054 0
Older adults - General sleep and sleep disturbances assessed using The Patient-Reported Outcomes Information System (PROMIS) Sleep Disturbance Scale
Timepoint [11] 417054 0
At baseline and after at least 17 weeks of the intervention.
Secondary outcome [12] 417056 0
Older adults — Physical activity assessed using the Incidental and Planned Exercise Questionnaire (IPEQ)
Timepoint [12] 417056 0
Intervention group: At baseline, after at least 17 weeks of the intervention, and at 6 and 12 months post intervention.

Control group: At baseline and after at least 17 weeks of the intervention.
Secondary outcome [13] 417057 0
Older adults — Cognitive function (Attention) using the NIH Flanker Inhibitory Control and Attention Test
Timepoint [13] 417057 0
At baseline and after at least 17 weeks of the intervention.
Secondary outcome [14] 417058 0
Older adults — Cognitive function (Episodic memory) using the NIH Picture Sequence Memory Test
Timepoint [14] 417058 0
At baseline and after at least 17 weeks of the intervention.
Secondary outcome [15] 417059 0
Older adults — Cognitive function (response inhibition) using the NIH Flanker Inhibitory Control and Attention Test
Timepoint [15] 417059 0
At baseline and after at least 17 weeks of the intervention.
Secondary outcome [16] 417062 0
Older adults — cognitive impairment assessed using the telephone Montreal Cognitive Assessment (MOCA)
Timepoint [16] 417062 0
Intervention group: At baseline, after at least 17 weeks of the intervention, and at 6 months post intervention.

Control group: At baseline and after at least 17 weeks of the intervention.
Secondary outcome [17] 417063 0
Older adults — Semantic memory using the semantic fluency test.
Timepoint [17] 417063 0
At baseline and after at least 17 weeks of the intervention.
Secondary outcome [18] 417064 0
Older adults — Rate of falls in each group: Falls will be monitored with monthly fall calendars.
Timepoint [18] 417064 0
Intervention group: Monthly after commencement of intervention till a maximum of 12 months post-intervention

Control group: Monthly after commencement of intervention till end of 20 weeks intervention
Secondary outcome [19] 417067 0
Older adults — Health services used using a monthly health services access questionnaire
Timepoint [19] 417067 0
Intervention group: Monthly after commencement of intervention till a maximum of 12 months post-intervention

Control group: Monthly after commencement of intervention till end of 20 weeks intervention
Secondary outcome [20] 417068 0
Older adults — individual's goals assessed using the Goal Attainment Scale (GAS) Light
Timepoint [20] 417068 0
Intervention group only: At baseline and at around week 17-20 of intervention
Secondary outcome [21] 417072 0
Children — Facial emotion recognition assessed using a normed database of facial expressions completed by children on a computer or paper-and-pencil version
Timepoint [21] 417072 0
At baseline and after week 20 of intervention (post-intervention)
Secondary outcome [22] 417074 0
Children — School readiness assessed using the parent-rated preschool version of the Strengths and Difficulties (SDQ) questionnaire.
Timepoint [22] 417074 0
At baseline and after week 20 of intervention (post-intervention)
Secondary outcome [23] 417075 0
Children — engagement levels (rated by educators) using a study-specific 4-point scale
Timepoint [23] 417075 0
At baseline, week 10 and after week 20 of intervention (post-intervention)
Secondary outcome [24] 417093 0
Children — Expressive language skills over 6 months assessed by Pearson’s Expressive Vocabulary test
Timepoint [24] 417093 0
At baseline and after week 20 of intervention (post-intervention)
Secondary outcome [25] 417926 0
Children — Attention to Others' Emotions scores assessed using the brief 35-item parent-rating questionnaire Measure of Empathy in Early Childhood (subscale).
Timepoint [25] 417926 0
At baseline and after week 20 of intervention (post-intervention)
Secondary outcome [26] 417927 0
Children — Personal Distress (i.e., Emotional Contagion/Affective Empathy) assessed using the brief 35-item parent-rating questionnaire Measure of Empathy in Early Childhood (subscale).
Timepoint [26] 417927 0
At baseline and after week 20 of intervention (post-intervention)
Secondary outcome [27] 417928 0
Children — Personal Distress-Fictional Characters scores assessed using the brief 35-item parent-rating questionnaire Measure of Empathy in Early Childhood (subscale).
Timepoint [27] 417928 0
At baseline and after week 20 of intervention (post-intervention)
Secondary outcome [28] 417929 0
Children — Prosocial Behavior scores assessed using the brief 35-item parent-rating questionnaire Measure of Empathy in Early Childhood (subscale).
Timepoint [28] 417929 0
At baseline and after week 20 of intervention (post-intervention)
Secondary outcome [29] 417930 0
Children — Sympathy scores assessed using the brief 35-item parent-rating questionnaire Measure of Empathy in Early Childhood (subscale).
Timepoint [29] 417930 0
At baseline and after week 20 of intervention (post-intervention)
Secondary outcome [30] 417935 0
Children - Theory of mind assessed using the Children’s Social Understanding Scale -Short Form (CSUS-SF)
Timepoint [30] 417935 0
At baseline and after week 20 of intervention (post-intervention)
Secondary outcome [31] 418069 0
Older adults — Cognitive function (executive function) using the NIH Dimensional Change Card Sort Test
Timepoint [31] 418069 0
At baseline and after at least 17 weeks of the intervention.

Eligibility
Key inclusion criteria
Inclusion criteria for adults:
• aged 65 or over
• able to walk approximately 6m with or without a walking aid (self-reported)
• able to sit and stand from a chair with arms
• a baseline Telephone Montreal Cognitive Assessment score of 19 or more
• residing in the community (may be receiving aged care at home but not residing in residential aged care)
• Fully vaccinated against COVID or other current infectious disease in accordance with current guidelines at the time of the trial
• Written/digital informed consent


Inclusion criteria for children:
• aged 3-4
• attending the preschool at the study site or an affiliated preschool
• not attending school the next year
• fully toilet trained
• who have provided verbal assent
• where parents/guardians have provided written informed consent
• Fully vaccinated against COVID-19 or other current infectious disease in accordance with current requirements at the time of the trial


Inclusion criteria for educators:
• Be a qualified pre-school educator at one of the participating pre-schools
Minimum age
3 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Key exclusion criteria for adults:
• has speech or sensory deficits that prevent interaction
• does not have an up to date/valid working with children check

Key exclusion criteria for children:
• has challenging behaviors that may affect their ability to participate in the program

Key exclusion criteria for educators:
• not familiar with the children who are participating in the research project

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)
Full blinding is not possible, but allocation will remain concealed where possible. Only one team member who is not involved in the recruitment and assessments of the participants will have access to the randomisation list.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation by preschool site. The Randomisation is blocked in 4 and 6 and was generated by an independent statistician based at UNSW.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/02/2023
Actual
14/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1100
Accrual to date
190
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 312707 0
Government body
Name [1] 312707 0
National Health and Medical Research Council (NHMRC)
Country [1] 312707 0
Australia
Primary sponsor type
Other
Name
The George Institute for Global Health
Address
Level 5, 1 King St, Newtown NSW 2042 Australia
Country
Australia
Secondary sponsor category [1] 314564 0
None
Name [1] 314564 0
Address [1] 314564 0
Country [1] 314564 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312008 0
University of New South Wales
Ethics committee address [1] 312008 0
Ethics committee country [1] 312008 0
Australia
Date submitted for ethics approval [1] 312008 0
Approval date [1] 312008 0
09/12/2022
Ethics approval number [1] 312008 0
HC220723

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

Contacts
Principal investigator
Name 123154 0
A/Prof Ruth Peters
Address 123154 0
The George Institute for Global Health
Level 5, 1 King St | Newtown NSW 2042 Australia
Country 123154 0
Australia
Phone 123154 0
+61 2 90652886
Fax 123154 0
Email 123154 0
rpeters@georgeinstitute.org.au
Contact person for public queries
Name 123155 0
Ruth Peters
Address 123155 0
The George Institute for Global Health
Level 5, 1 King St | Newtown NSW 2042 Australia
Country 123155 0
Australia
Phone 123155 0
+61 2 90652886
Fax 123155 0
Email 123155 0
rpeters@georgeinstitute.org.au
Contact person for scientific queries
Name 123156 0
Ruth Peters
Address 123156 0
The George Institute for Global Health
Level 5, 1 King St | Newtown NSW 2042 Australia
Country 123156 0
Australia
Phone 123156 0
+61 290652886
Fax 123156 0
Email 123156 0
rpeters@georgeinstitute.org.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.