Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000488606p
Ethics application status
Submitted, not yet approved
Date submitted
27/03/2023
Date registered
12/05/2023
Date last updated
12/05/2023
Date data sharing statement initially provided
12/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of telemedicine and cognitive behavioural therapy on sleep and health outcomes in type 2 diabetes patients: a randomized controlled trial
Scientific title
The effect of telemedicine and cognitive behavioural therapy on sleep and health outcomes in type 2 diabetes patients: a randomized controlled trial
Secondary ID [1] 309311 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 2 diabetes 329499 0
insomnia 329500 0
Condition category
Condition code
Metabolic and Endocrine 326435 326435 0 0
Diabetes
Mental Health 326436 326436 0 0
Other mental health disorders
Neurological 326509 326509 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive behavioural therapy intervention targeting both type 2 diabetes and insomnia delivered by a therapist who have received full training for cognitive behavioural therapy intervention delivery. The intervention contains 10 online sessions delivered weekly in groups of 10 to 12. The approximate duration of each session is 60 minutes.

Participants receive online reading materials before each session. The online reading materials are designed specifically for this study and participants are recommended (not compulsory) to read the materials prior to the session.

Contents included in the intervention are knowledges and skills on sleep restriction, stimulus control, sleep hygiene, cognitive restructure, relaxation training, self-monitoring of blood glucose, diet, exercise and substance intake management. The skills participants are prescribed in the cognitive behavioural therapy include: (1) keep a sleep diary for self-monitoring of sleep quality; (2) develop and keep a regulated sleep schedule; (3) identify and avoid the behaviours that are not beneficial for sleep and blood glucose control; (4) identify and change the understandings and thoughts that are not beneficial for sleep and blood glucose control; (5) set up bedroom environment that promote sleep; (6) physical and mental relaxation skills; (7) skills for self-monitoring of blood glucose; (8) develop a balanced diet; (9) develop a healthy exercise plan; (10) communication skills to share own difficulties and feelings to others. Practice of these skills are part of the weekly sessions leaded by the therapist. Patients are also required to practice these skills after the weekly sessions and share their progress in the following sessions.

Strategies used to monitor and ensure the adherence to the intervention include:
(1) Participants are required to keep their sleep diary and record their blood glucose at least five days per week and report to the therapist every week.
(2) Participants are required to complete a homework containing 3-5 multiple choice questions about the session contents after each session and report back to the therapist before the beginning of next session.
(3) There will be a short telephone chat between each participant and the therapist every week (approximately 15 minutes). Therapist will give comments on sleep diaries, blood glucose records and homework from the previous session, and answer any questions raised during the intervention.
(4) An attendance checklist will be used to record the participance of the weekly sessions. Participants completing all sessions will receive a certificate of completion at the end of the project.

Polysomnography devices:
Participants will be informed that they can use polysomnography devices provided by the hospital to monitor their sleep during the participant recruiting process. The PSG device used is the "Alice NightOne" home sleep testing device provided by PHILIPS RESPIRONICS (Primary DI Number: 00606959039797).
Participants will receive full instructions on using the devices from the staff in the hospital. Participants will be required to use the devices for only one night at three timepoints in during the research (baseline, 3 months and 6 months), then return the device to the hospital.
Intervention code [1] 325746 0
Rehabilitation
Intervention code [2] 325747 0
Behaviour
Comparator / control treatment
Sleep hygiene education and type 2 diabetes information only during the intervention period. Self-help material of cognitive behavioural therapy intervention after the end of the project. The sleep hygiene education and type 2 diabetes information provided to this control group is the same as is provided to the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 334276 0
Insomnia severity measured by total score of Insomnia Severity Index
Timepoint [1] 334276 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention (primary endpoint), 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Primary outcome [2] 334277 0
Overall sleep quality measured by total score of Pittsburgh Sleep Quality Index
Timepoint [2] 334277 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention (primary endpoint), 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Primary outcome [3] 334278 0
Total sleep time (minutes) from self-recorded sleep diaries and polysomnography devices (if applicable)
Timepoint [3] 334278 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention (primary endpoint), 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [1] 420099 0
Sleep efficiency (%) from self-recorded sleep diaries and polysomnography devices (if applicable)

This is also a primary outcome
Timepoint [1] 420099 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention (primary endpoint), 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [2] 420100 0
Sleep onset latency (mins) from self-recorded sleep diaries and polysomnography devices (if applicable)

This is also a primary outcome
Timepoint [2] 420100 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention (primary endpoint), 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [3] 420101 0
Wake after sleep onset (mins) from self-recorded sleep diaries and polysomnography devices (if applicable)

This is also a primary outcome.
Timepoint [3] 420101 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention (primary endpoint), 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [4] 420102 0
Total time in bed (mins) from self-recorded sleep diaries and polysomnography devices (if applicable)

This is also a primary outcome.
Timepoint [4] 420102 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention (primary endpoint), 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [5] 420103 0
Number of awakenings from self-recorded sleep diaries and polysomnography devices (if applicable)

This is also a primary outcome.
Timepoint [5] 420103 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention (primary endpoint), 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [6] 420104 0
Self-rated sleep quality (1-5 points) from self-recorded sleep diaries

This is also a primary outcome.
Timepoint [6] 420104 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention (primary endpoint), 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [7] 420105 0
Fasting blood glucose (mmol/l) from blood samples
Timepoint [7] 420105 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention , 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [8] 420106 0
Glycated Hemoglobin (HbA1c, %) from blood samples
Timepoint [8] 420106 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [9] 420107 0
Total cholesterol (mmol/l) from blood samples
Timepoint [9] 420107 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [10] 420348 0
High density lipoprotein cholesterol (mmol/l) from blood samples
Timepoint [10] 420348 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [11] 420349 0
Low density lipoprotein cholesterol (mmol/l) from blood samples
Timepoint [11] 420349 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [12] 420350 0
Triglyceride (mmol/l) from blood samples
Timepoint [12] 420350 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [13] 420351 0
Serum creatinine (µmol/l) from blood samples
Timepoint [13] 420351 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [14] 420352 0
Blood urea nitrogen (mmol/l) from blood samples
Timepoint [14] 420352 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [15] 420353 0
Uric acid (µmol/l) from blood samples
Timepoint [15] 420353 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [16] 420354 0
Systolic blood pressure (SBP, mmhg) assessed by manual sphygmomanometer
Timepoint [16] 420354 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [17] 420355 0
Diastolic blood pressure (DBP, mmhg) assessed by manual sphygmomanometer
Timepoint [17] 420355 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [18] 420356 0
Weight (kg) measured by weight scale
Timepoint [18] 420356 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [19] 420357 0
Body Mass Index (BMI) calculated through weight measured by weight scale and height measured by stadiometer
Timepoint [19] 420357 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [20] 420358 0
Waist circumference measured by tape measure
Timepoint [20] 420358 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [21] 420359 0
Hip circumference measured by tape measure
Timepoint [21] 420359 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [22] 420360 0
Waist-hip ratio calculated through waist circumference measured by tape measure and hip circumference measured by tape measure
Timepoint [22] 420360 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [23] 420361 0
Depression measured by total score of Hamilton Depression Rating Scale
Timepoint [23] 420361 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [24] 420362 0
Anxiety measured by the total score of Hamilton Anxiety Rating Scale
Timepoint [24] 420362 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [25] 420363 0
Fatigue level measured by total score of Multidimensional Fatigue Inventory
Timepoint [25] 420363 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow-up, secondary endpoint)
Secondary outcome [26] 420364 0
Quality of life measured by total score of 12-question short-form survey
Timepoint [26] 420364 0
Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow-up, secondary endpoint)

Eligibility
Key inclusion criteria
(1) Patients meet the diagnostic criteria for both type 2 diabetes and insomnia, and type 2 diabetes is the primary cause of insomnia
(2) Patients aged over 18
(3) Patients not currently participating in similar intervention programs
(4) Patients fully understand the program contents, willing to participate and signed the informed consent form
(5) Patients able to use smart phones or computers to receive and view intervention materials

Diagnostic criteria for type 2 diabetes:
(1) Fasting plasma glucose greater than or equal to 7.0 mmol/l (fasting time >8 hours)
(2) Two-hour postprandial blood glucose greater than or equal to 11.1mmol/l
(3) Random plasma glucose greater than or equal to 11.1 mmol/L in patients with classic symptoms of hyperglycemia or hyperglycemic crisis
(4) Glycated Hemoglobin (HbA1c) greater than or equal to 6.5%

Screening for insomnia: Insomnia Severity Index score greater than 10

To determined if type 2 diabetes is the primary cause of insomnia:
(1) Insomnia symptoms occurs or worsens after the diagnosis of type 2 diabetes.
(2) Patients have worries about type 2 diabetes
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Patients with severe primary diseases, including severe heart, liver or renal system diseases and cancer
(2) Patients with severe psychiatric diseases that affect regular cognition and communication, including severe depression (HAMD score>18), anxiety (HAMA score>14) and schizophrenia
(3) Patients diagnosed with sleep disorders other than insomnia, including obstructive sleep apnoea, restless leg syndrome, parasomnia and hypersomnia through self-report or PSG devices.
(4) Patients who are pregnant
(5) Patients who are illiterate and cannot understand the intervention contents.

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)
Allocation is not concealed because the person responsible for participant recruitment and intervention delivery is the same.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (SPSS)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size is calculated through the equation: n=(2*((Zalpha +Z1-ß)^2)*s^2)/delta^2
Zalpha is a constant decided by the accepted alpha error and whether the study is one-sided or two-sided effect. Z1-ß is a constant set by the power of the study. s is estimated standard deviation and delta is the estimated effect size.
In this study, we accept a p value<0.05 as statistically significant and a study power of 80%. A two-tailed test is used, as the results could be bidirectional. Therefore, the Zalpha value is 1.96, and Z1-ß value is 0.8416. Choosing sleep efficiency as main outcome and based on the published studies, the estimated standard deviation is 0.96, and the estimated effect size is 39%. The calculated sample size for this study is at least 102 patients per arm. Considering a 30% attrition rate and 30% non-response rate in the study, the final sample size in this study is at least 326 (163 patients per arm).

The data analysis process involve:
1. Description of baseline characteristics (in means, standard deviations and percentages)
2. Identifying confounding factors using Independent samples t-test (when normally distributed) or Mann-Whitney U-test (when not normally distributed) or Chi Square test (for categorical variables).
3. Intention-to-treat method for final data analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/05/2023
Actual
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
326
Accrual to date
Final
Recruitment outside Australia
Country [1] 25350 0
China
State/province [1] 25350 0
Zhejiang

Funding & Sponsors
Funding source category [1] 313504 0
University
Name [1] 313504 0
Griffith University International Postgraduate Research Scholarship
Country [1] 313504 0
Australia
Primary sponsor type
University
Name
School of Medicine and Dentistry, Griffith University
Address
1 Parklands Dr, Southport QLD 4215
Country
Australia
Secondary sponsor category [1] 315279 0
Hospital
Name [1] 315279 0
Ningbo First Hospital
Address [1] 315279 0
59 Liutin Street, Haishu District, Ningbo, Zhejiang, China 315010
Country [1] 315279 0
China

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312691 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 312691 0
1 Parklands Dr, Southport QLD 4215
Ethics committee country [1] 312691 0
Australia
Date submitted for ethics approval [1] 312691 0
25/03/2023
Approval date [1] 312691 0
Ethics approval number [1] 312691 0
Ethics committee name [2] 312692 0
Ningbo First Hospital Human Research Ethics Committee
Ethics committee address [2] 312692 0
59 Liutin Street, Haishu District, Ningbo, China 315010
Ethics committee country [2] 312692 0
China
Date submitted for ethics approval [2] 312692 0
10/04/2023
Approval date [2] 312692 0
Ethics approval number [2] 312692 0

Summary
Brief summary
The aim of this project is to evaluate the effect of internet-delivered CBT intervention on sleep quality, blood glucose level, blood lipid level, kidney function, blood pressure, obesity, psychiatric diseases, fatigue and quality of life in adults with T2DM and insomnia.

The detailed research objectives include:
(1) To improve the overall sleep quality and sleep efficiency using internet-delivered CBT based intervention in adults with T2DM.
(2) To improve the overall blood glucose level, blood lipid level, kidney function, blood pressure and obesity through internet-delivered CBT based intervention in adults with T2DM
(3) To reduce depression, anxiety, fatigue and improve quality-of-life through internet-delivered CBT based intervention in adults with T2DM.

The research hypothesis are as follows:
(1) It is hypothesized that internet-delivered CBT-based intervention can provide positive effect in improving sleep outcomes, including insomnia severity measured by Insomnia Severity Index, sleep quality measured by Pittsburgh Sleep Quality Index, total sleep time, sleep efficiency, sleep onset latency, wake time after sleep onset and number of awakenings.
(2) It is hypothesized that internet-delivered CBT-based intervention can improve biochemical indicators relating to T2DM, blood lipid and kidney function, including fasting blood glucose, Glycated Hemoglobin (HbA1c), total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), triglyceride (TG), serum creatinine, blood urea nitrogen, uric acid, blood pressure, body weight, body mass index (BMI) and waist-hip ratio (WHR).
(3) It is also hypothesized that the internet-delivered CBT-based intervention can improve other health outcomes, including depression, anxiety, fatigue and quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125578 0
Prof Jing Sun
Address 125578 0
School of Medicine and Dentistry, Griffith University, 8.23, G40, 1 Parklands Dr, Southport QLD 4215
Country 125578 0
Australia
Phone 125578 0
+61 7 567 80924
Fax 125578 0
Email 125578 0
j.sun@griffith.edu.au
Contact person for public queries
Name 125579 0
Prof Jing Sun
Address 125579 0
School of Medicine and Dentistry, Griffith University, 8.23, G40, 1 Parklands Dr, Southport QLD 4215
Country 125579 0
Australia
Phone 125579 0
+61 7 567 80924
Fax 125579 0
Email 125579 0
j.sun@griffith.edu.au
Contact person for scientific queries
Name 125580 0
Prof Jing Sun
Address 125580 0
School of Medicine and Dentistry, Griffith University, 8.23, G40, 1 Parklands Dr, Southport QLD 4215
Country 125580 0
Australia
Phone 125580 0
+61 7 567 80924
Fax 125580 0
Email 125580 0
j.sun@griffith.edu.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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18700Study protocol    385630-(Uploaded-27-03-2023-12-38-38)-Study-related document.docx
18701Informed consent form    385630-(Uploaded-27-03-2023-12-40-49)-Study-related document.doc



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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