Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000321145
Ethics application status
Approved
Date submitted
7/02/2019
Date registered
1/03/2019
Date last updated
25/02/2020
Date data sharing statement initially provided
1/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A health-coaching program for stroke survivors and their family caregivers during the hospital to home transition in Chongqing, China
Scientific title
Effectiveness of a nurse-led health-coaching program for stroke survivors and their family caregivers during the hospital to home transition in Chongqing, China: A randomized controlled trial
Secondary ID [1] 296171 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 309799 0
Condition category
Condition code
Stroke 308593 308593 0 0
Ischaemic
Stroke 308594 308594 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A two-stage intervention for the intervention group will be conducted as described in the following:
Stage I: Interventions at hospitals
Individualised health coaching: the intervention nurses will provide stroke survivors and their family caregivers with two face-to-face individualised health coaching sessions (20-30 minutes each time) that include: (1) how to set out realistic and achievable care goals; (2) self-care skills demonstration; (3) safety home environment demonstration; (4) functional recovery plan; (5) prevention of complications and secondary stroke; chronic condition management and (6) medication management. All health coaching sessions will be based on the “Health coaching intervention program guide” to standardise interventions in the study. The “Health coaching intervention program guide” is designed specifically for this study and is based on a systematic review and meta-analysis prior to the development of this study protocol. The “Post-stroke follow-up checklist” is designed specifically for this study to monitor intervention fidelity.
1. Stroke survivors and caregivers will be invited to establish their transition care goals and develop personal action plans. A ‘Health coaching diary-Patient/caregiver version’ and a ‘Health coaching record- intervention nurse version’ will be used to record the goals, actions, progresses, problem solving and outcomes.
2. Prior to discharge, the intervention nurse will demonstrate self-care skills or skills that are required for participants in providing activity of daily living (ADL), instrumental activity of daily living (IADL) and social engagement when appropriate
3. Before discharge to home-care setting, stroke survivors and caregivers will be invited to participate one of the two face-to-face individualised health coaching sessions to discuss a safe home environment, including safety toileting, walking, sleeping. Home environment modification will be undertaken prior to discharge when it needed.
4. Individualised functional recovery and exercise plan will be conducted based on the plan provided by the patient’s medical specialist. Intervention nurse will discuss the plan and demonstrate skills when appropriate. The functional recovery plan will be recorded in the “Health Coaching Diary-Patient/caregiver version”.
5. Prior to discharge, stroke survivors will be given individualized treatment and rehabilitation plan ordered by the medical specialists, have opportunities to discuss and clarify the plan and receive medication education from the intervention nurse. The treatment and rehabilitation plan will be recorded in the “Health Coaching Diary-Patient/carer version”.
6. The intervention nurse will demonstrate how to prevent, identify and manage stroke-related complications.

Stage II: Follow-up Interventions in the first 12 weeks after discharge to homecare setting
The intervention nurse will provide the stroke survivor-caregiver dyads with phone support and face-to-face meetings in outpatient clinics in a 12-weeks period after discharge from hospital.
1. Weekly Telephone support
Stroke survivors and caregivers will receive weekly telephone call at home from the intervention nurse. The coaching via phone conversations will be conducted based on the “Post-stroke follow-up checklist” to discuss concerns and problems arising from the transition care, the approaches, resources and strategies to resolve the problems. The “Post-stroke follow-up checklist” is designed specifically for this study to monitor the intervention fidelity. . The coaches will also motivate stroke survivors and caregivers to monitor their care activities and outcomes towards their transition care goals. Each phone call lasts about 10-15 minutes. Participants will be encouraged to make phone contact with their health coaches to seek help when necessary.
2. Bi-weekly face-to-face coaching activities at the outpatient departments
Stroke survivors will engage in rehabilitation or appointment with specialists at the outpatient clinics bi-weekly. The intervention nurses will use the opportunity to have a bi-weekly meeting with survivors-caregiver dyads. Participants will be asked to bring their coaching diary to the meeting. The intervention nurses will analyse the coaching diary, discuss with them about concerns and problems they have, coaching them problem-solving skills based on their needs, introduce resources they need, reinforce self-care knowledge and skills, and motivate them to self-monitor the process and outcomes towards their care goals. Each bi-weekly face-to-face coaching activities lasts about 20 minutes.
Intervention code [1] 312501 0
Rehabilitation
Comparator / control treatment
Participants in the usual group will receive usual stroke-related patient education and information sheet about post-stroke care and is provided by nurses. The content of the education include dietary care, prevention of complications, mobility and outpatient follow-up. In the follow-up after discharge, the nurse will ring patients twice: at the end of the first week and the fourth week to remind the patient of their follow-up at the outpatient clinics.
Control group
Active

Outcomes
Primary outcome [1] 307549 0
Self-efficacy assessed using the Stroke Self-efficacy Questionnaire (SSEQ)
Timepoint [1] 307549 0
At baseline (T1, before intervention), intermediate (T2, 12-weeks after intervention) and endpoint (T3, 24 weeks after intervention)
Primary outcome [2] 307551 0
Quality of life assessed using the short version of Stroke-specific quality of life scale (SSQoL-12)
Timepoint [2] 307551 0
At baseline (T1, before intervention), intermediate (T2, 12-weeks after intervention) and endpoint (T3, 24 weeks after intervention)
Secondary outcome [1] 352280 0
Stroke-related health knowledge assessed using the Chinese Stroke Prevention Knowledge Questionnaire (SPKQ)
Timepoint [1] 352280 0
At baseline, intermediate (12-weeks after discharge) and endpoint (24 weeks after discharge)
Secondary outcome [2] 352282 0
Functional ability is a composite outcome which will be assessed using the Activities of daily living (ADL), Instrumental Activities of daily living (IADL) and Social Support Rating Scale (SSRS).
Timepoint [2] 352282 0
At baseline (T1, before intervention), intermediate (T2, 12-weeks after intervention) and endpoint (T3, 24 weeks after intervention)
Secondary outcome [3] 352283 0
Caregiver-related burden assessed using the Chinese version of Modified Caregiver Strain Index (CSI)
Timepoint [3] 352283 0
At baseline (T1, before intervention), intermediate (T2, 12-weeks after intervention) and endpoint (T3, 24 weeks after intervention)

Eligibility
Key inclusion criteria
Inclusion criteria for stroke survivors
Participants will meet all of these inclusion criteria: (1) aged 18 or over; (2) first-time stroke survivors (ischemic or hemorrhagic stroke); (3) will be discharged to home-care setting within a week; (4) be autonomous, and have no cognitive impairment ( Montreal cognitive assessment score greater than or equal to 23); (5) Not participating in other clinical trials at the same time; (6) can speak Chinese and without aphasic; (7) willing to participate in this study.
Inclusion criteria for caregivers
Caregivers will meet all of these inclusion criteria: (1) aged 18 or over; (2) be the primary caregiver.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for stroke survivors
(1) Comorbidities such as severe circulation, digestive, immune, blood and endocrine systems disorders; (2) Previous cerebrovascular disease with impaired limb function; (3) Previous mental illness (such as Panic disorder, PTSD, Psychosis, Schizoaffective disorder, Schizophrenia); (4) Previous cognitive disabilities.
Exclusion criteria for caregivers
(1) Under 18; (2) mental or cognitive disabilities.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment is ensured by the research assistant into sequentially numbered, opaque, sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will allocate eligibility stroke survivors and caregivers’ dyads to the intervention or the control group using simple randomization, with an equal allocation ration 1:1, using PASS randomisation procedure applying maximum allowable % deviation. A research assistant who is not involved in recruitment, intervention allocation, and outcome assessment will generate the randomise blocks.
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
Sample size estimates on the basis of two primary stroke survivors outcome measures: the self-efficacy (Riazi, Aspden & Jones 2014) and quality of life (Chen et al. 2012). We generated estimated based on the stroke self-efficacy questionnaire from a previous randomised controlled trial (Lo, Chang & Chau 2018). Considering Medium effect from Lo’s paper (d=0 .5), with a type I error of alpha 0.05, and a power of 80%. Expecting a 10% dropout rate, we would require 70 participants per treatment group and at least 140 stroke survivors and caregivers dyads have to be recruited.

Statistical analysis will be performed using the IBM SPSS Statistics version 25. Descriptive statistics will be produced including frequencies and percentages for categorical data and means, standard deviation for quantitative normally distributed data or medians and interquartile range for non-normal distributions. Chi-square tests and independent t-tests will be used to compare the demographic and clinical characteristics (e.g. gender, age, education level, type of stroke), and mean weighted scores of outcomes between the intervention and the usual care groups.
The researcher will calculate 12-weeks and 24-weeks change in the outcome measures from the baseline to follow-ups. To estimate mean changes over time in the primary and secondary outcomes, linear mixed model for repeated measures will be used to assess the differences between the intervention and the usual care groups. Fixed effects in the model will include intervention, time, and the two-way interaction of intervention and time. The model will also include participant-level random effects to account for correlation between participants’ repeated measures over time. The proposed analyses focus on an intervention group by time effect in the generalized linear mixed model.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/03/2019
Actual
8/04/2019
Date of last participant enrolment
Anticipated
Actual
2/05/2019
Date of last data collection
Anticipated
Actual
5/11/2019
Sample size
Target
140
Accrual to date
Final
140
Recruitment outside Australia
Country [1] 20867 0
China
State/province [1] 20867 0
Chongqing

Funding & Sponsors
Funding source category [1] 300763 0
University
Name [1] 300763 0
Postgraduate Research Student Maintenance (RSM), Flinders University.
Country [1] 300763 0
Australia
Primary sponsor type
University
Name
College of Nursing and Health Sciences, Flinders University.
Address
College of Nursing and Health Sciences, Flinders University.
Sturt Road, Bedford Park . South Australia. 5042
Country
Australia
Secondary sponsor category [1] 301904 0
None
Name [1] 301904 0
Address [1] 301904 0
Country [1] 301904 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301544 0
the Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 301544 0
Ethics committee country [1] 301544 0
Australia
Date submitted for ethics approval [1] 301544 0
03/09/2018
Approval date [1] 301544 0
20/12/2018
Ethics approval number [1] 301544 0
HREC/18/SAC/265

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

Contacts
Principal investigator
Name 87338 0
Prof Lily Dongxia Xiao
Address 87338 0
College of Nursing and Health Sciences. Flinders University
Sturt Road, Bedford Park, South Australia 5042
GPO Box 2100 Adelaide SA
Country 87338 0
Australia
Phone 87338 0
+61 8 82013419
Fax 87338 0
+61 8 82761602
Email 87338 0
[email protected]
Contact person for public queries
Name 87339 0
Lily Dongxia Xiao
Address 87339 0
College of Nursing and Health Sciences. Flinders University
Sturt Road, Bedford Park, South Australia 5042
GPO Box 2100 Adelaide SA
Country 87339 0
Australia
Phone 87339 0
+61 8 82013419
Fax 87339 0
+61 8 82761602
Email 87339 0
[email protected]
Contact person for scientific queries
Name 87340 0
Lily Dongxia Xiao
Address 87340 0
College of Nursing and Health Sciences. Flinders University
Sturt Road, Bedford Park, South Australia 5042
GPO Box 2100 Adelaide SA
Country 87340 0
Australia
Phone 87340 0
+61 8 82013419
Fax 87340 0
+61 8 82761602
Email 87340 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual, de-identified data underlying published results will be shared such as the scores of each time point of participants
When will data be available (start and end dates)?
Immediately after the outcomes in this project published in the PhD dissemination and other publications related to this topic. No end date
Available to whom?
Available to researchers for academic use such as meta-analysis plan
Available for what types of analyses?
Meta-analysis
How or where can data be obtained?
Access to contact and get the approvals by principal investigator in this project


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
SourceTitleYear of PublicationDOI
EmbaseA nurse-led health coaching intervention for stroke survivors and their family caregivers in hospital to home transition care in Chongqing, China: A study protocol for a randomized controlled trial.2020https://dx.doi.org/10.1186/s13063-020-4156-z
N.B. These documents automatically identified may not have been verified by the study sponsor.