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Trial registered on ANZCTR


Registration number
ACTRN12617001352392
Ethics application status
Approved
Date submitted
20/09/2017
Date registered
26/09/2017
Date last updated
3/06/2019
Date data sharing statement initially provided
3/06/2019
Date results provided
3/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A hypertension management program for community-dwelling older people with diabetes in China
Scientific title
The effect of a hypertension management program on blood pressure in community-dwelling older people with diabetes: A cluster randomized controlled trial.
Secondary ID [1] 290874 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension
 301577 0
Type II diabetes 301578 0
Condition category
Condition code
Cardiovascular 301288 301288 0 0
Hypertension
Metabolic and Endocrine 301289 301289 0 0
Diabetes
Public Health 304161 304161 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention program will start from hospital via an individualised discharge education provided by the patient’s in-charge nurse and the medical specialist (1st stage of intervention). After patients are discharged, in addition to the usual follow-up in the outpatient clinic of hospital, they will be referred to the nearest Community Health Service Centre to receive 6 months follow-up intervention provided by general practitioners (GPs) and community nurses (2nd stage of intervention). Health professionals from both hospital and community health service centres will work in a collaborative way to implement the post-discharge interventions.

Stage 1: Interventions at hospital:
1. Individualised discharge education:
1.1. Patients will be given two face-to-face individualised health education sessions specific to diabetic patients with hypertension by the in-charge nurse, with one session 3 days prior to discharge and one on day of discharge. The health education includes health behaviour education, disease-associated education and medication education with 15 minutes for each session. A geriatrics conditions screening will also be undertaken using the widely recognised evidence-based screening tool “Fulmer Spices Comprehensive Assessment Tool for Older Adults” (Aronow et al., 2014). Education on preventing and managing geriatric conditions will be provided by the in-charge nurse based on the finding from the screening.
1.2. Patients will be asked to establish lifestyle modification goals and develop personal action plans with the in-charge nurse. Patients will be provided an “Intervention diary-patient version” (refer to Additional file 1 in ANZCTR registration record) to document their lifestyle modification goals, personal action plans, progress towards the goals, medication adherence, adverse events and unplanned hospital admission/ the use of emergency care service.
1.3. Patients will be asked to discuss and establish their diet plan with the in-charge nurse. Diet plan will be recorded in “intervention diary-patient version”.
1.4. Prior to discharge, patients will be given an individualized medication treatment plan by the medical specialist. Individualized medication treatment will be recorded in the “intervention diary-patient version”.
1.5. When patients are discharged from hospital, they will be referred to the community health service centers by the in-charge nurse for regular follow up over 6 months. In addition, an “Intervention record-community nurse and GP version” (refer to Additional file 2 in ANZCTR registration record) will be sent to the community nurse by the in-charge nurse on discharge to record required post-discharge interventions and outcomes.
1.6. Discharge planning and referral
1.6.1 The in-charge nurse at the hospital will contact the GP and nurse in community health service centers to fill in the two-way referral letter for patients, and help patients to contact the nearby community health service centers for follow up visit. Patients will be advised the community health service centers they referred to, and the name and contacts of GP/nurse in community health service centers.
1.6.2 Data in relation to the patient’s demographic information, pharmacotherapy history, and other clinical information will be sent to the community nurse by the in-charge nurse on discharge.
1.6.3 Three copies of two-way referral letter will be printed and delivered to the doctor/nurse in hospital,patient and GP/nurse at community health service centers in order to establish the collaboration among them.
1.6.4 Patients will take the referral letter and discharge abstract to the community health service centers for the follow up visit.
1.6.5 The in-charge nurse will keep track of the patient’s referral progress through contact with the patients and community nurses, and ensure patients are referred to the community health service center.

Stage 2: Regular follow up interventions over 6 months at community health service centers:
1. Fortnightly phone call:
Patients will receive a fortnightly phone call at home from the community nurse to monitor their progress towards setting goals and medication adherence. The approximate duration of follow-up phone calls at each time will be 10 minutes.
2. Monthly community health service centers visit:
Patients will be asked to visit the community nurse and GP at the community health service centers every month for follow up visits. The approximate duration of follow-up visit at each time will be 30 minutes.
2.1 Patients will receive blood pressure measurement every month by the community nurse.
2.2 Patients will receive a review and assessment from the community nurse on their adherence to medication and lifestyle recommendations, and their progress toward lifestyle modification goals. The diet management of patients will follow the guideline of Dietary Approaches to Stop Hypertension (DASH).
2.3 Patients will receive reinforced health education from the community nurse to improve their self-management ability and treatment adherence. Patient will be given health education on preventing or treating geriatric conditions based on the “Fulmer Spices Comprehensive Assessment Tool for Older Adults”.
2.4 Patients will receive an assessment from the GP on their clinical outcomes, problems of non-adherence to medication, medication side effects, drug therapy problems, drug-related needs and clinical events occurred.
2.5 Patients will be asked to discuss individualized treatment plan and medication adjustment with GP.
2.6 Patients will be asked to document their medication changes in the “intervention diary-patient version”.
2.7 Patients will be reminded the categories, dosage and frequency of medication required to be taken prior to the next visit by community nurse.
2.8 The GP will discuss with the medical specialist at hospital via email or telephone when necessary to adjust medication. BP, HbA1c and lipid readings will be recorded by the community nurses and formatted as monthly report and then sent to medical specialists for review. Urgent symptoms will be communicated to the medical specialist immediately for additional orders by the GP.

Intervention fidelity
The items of interventions recorded by both community health professionals and patients include (1) Intervention diary- patient version, (2) Intervention record-community nurse and GP version. The community nurses and GPs will be asked to record the interventions they provide to patients. Compliance with required interventions will be matched using these two tools.
Intervention code [1] 296821 0
Lifestyle
Intervention code [2] 298496 0
Treatment: Other
Comparator / control treatment
Patients in the usual care group will receive usual discharge education in the hospital. After they are discharged, they will go to their usual outpatient clinic of the hospital to receive usual follow-up and outcome measures at three months and six months.
Control group
Active

Outcomes
Primary outcome [1] 302605 0
systolic blood pressure at six months follow-up adjusted for baseline value. It will be assessed by automatic sphygmomanometer.
Timepoint [1] 302605 0
6 months after discharge
Secondary outcome [1] 336481 0
Hypertension and diabetes-related health knowledge score measured by the combination of Hypertension Knowledge Level Scale (HK-LS) and Diabetes Knowledge Questionnaire (DKQ), with baseline value adjusted. This is a composite secondary outcome,
Timepoint [1] 336481 0
6 months after discharge
Secondary outcome [2] 336519 0
Medication adherence and health lifestyle adherence scores measured by the treatment adherence questionnaire of patients with hypertension (TAQPH), with baseline value adjusted
Timepoint [2] 336519 0
6 months after discharge
Secondary outcome [3] 336520 0
HbA1c recorded from medical records of patients, with baseline value adjusted
Timepoint [3] 336520 0
6 months after discharge
Secondary outcome [4] 336521 0
Quality of life measured by the hypertension scale of the system of Quality of Life Instruments for Chronic Diseases (QLICD-HY), with baseline value adjusted
Timepoint [4] 336521 0
6 months after discharge
Secondary outcome [5] 336522 0
The numbers of adverse events and complications associated with hypertension, diabetes, treatments and geriatric syndromes.

It will be recorded in the “Intervention diary-patient version” by patients in the intervention group. Patients in the usual care group will record it in a Usual care Table. “Intervention diary-patient version” and Usual care Table are two instruments developed specifically for this study. The possible adverse events and complications include: falls and falls-related injuries; fracture; dizziness; chest distress; stomach disorder, headache; cough; dyspnea; vomit.
Timepoint [5] 336522 0
6 months after discharge
Secondary outcome [6] 336523 0
The numbers of unplanned hospital admission/the use of emergency care service due to uncontrolled hypertension, diabetes and geriatric syndromes.

It will be recorded in the “Intervention diary-patient version” by patients in the intervention group. Patients in the usual care group will record it in a Usual care Table. “Intervention diary-patient version” and Usual care Table are two instruments developed specifically for this study. This is a composite secondary outcome.
Timepoint [6] 336523 0
6 months after discharge
Secondary outcome [7] 339032 0
lipid values recorded from medical records of patients, with baseline value adjusted
Timepoint [7] 339032 0
6 months after discharge

Eligibility
Key inclusion criteria
1). Receiving care for both type 2 diabetes and hypertension in two tertiary hospitals and two secondary hospitals.
2). diagnosed with coexisting type 2 diabetes and hypertension
3). aged higher than 60 years
4). fit for discharge justified by the specialist.
5). without cognitive impairment (assessed by the Mini-Mental State Examination)
6) reside in residential areas where the 6 community health service centers provide care services.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1). no diagnosis of diabetes and hypertension;
2). type 1 diabetes;
3). inability to participate in the study because of severe organ damage, disability, cognitive impairment and other life-threatening disease;
4). unwilling to return to community health service centre for follow-up visits;
5). living outside of these six communities.

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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A cluster randomized controlled trial will be applied. The trial will commence at hospitals via discharge and continue at community health service centers for 6 months in Nanchang, a capital city of Jiangxi Province in China. Modified stratified random sampling will be applied to recruit participants. This cluster design will minimize the risk of contamination between intervention and control groups and also reflect the classification of public hospitals in China. Healthcare facilities are classified at three levels, namely community health service centers, secondary hospitals and tertiary hospitals. Tertiary hospitals are the final referral hospitals and provide more comprehensive care services for patients compared with secondary hospitals.

Participants will be recruited from hospitals and continue the trial at community health service centers. Randomization was performed based on the clusters rather than participants. There are 6 secondary hospitals and 5 tertiary hospitals that provide in-patient care for patients with diabetes and hypertension in Nanchang. As part of the ethics application processes, researchers in the project sent out invitations to all of these 11 public hospitals in Nanchang and informed them that 2 secondary hospitals and 2 tertiary hospitals would be randomly selected to the trial on receiving their responses. The numbers of hospitals to be included in the trial was estimated on the sample size calculation. In total, 6 secondary hospitals and 5 tertiary hospitals agreed to participate in the trial. Hospitals that agreed to participate in the trial were given a unique code number. SPSS version 22.0 was used to randomly select 2 hospitals from each level. There are 2 wards in each participating secondary hospitals and 3 wards in each tertiary hospital that provide in-patient care for patients with diabetes and hypertension. These wards were given a unique code number. SPSS version 22.0 was used to randomly assign 2 wards from secondary hospitals and 3 wards from tertiary hospitals to intervention group or usual care groups respectively. The group assignment was undertaken by a PhD fellow who was not involved in the trial and blind to the wards.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was estimated on the basis of a previous randomised controlled trial study in relation to hypertension management for diabetic patients (Edelman et al., 2010). The 7.3 mm Hg significant difference in systolic blood pressure (SBP) has been found in their study with a standard deviation of 12.1 mm Hg. Since randomization is done by wards (clusters), the sample size was adjusted in order to take into account the design effect. An intra-class correlation coefficient was assumed to 0.05 and a cluster size of 25 participants, giving a design effect of 1.48. With these assumptions, a sample size of 5 clusters per group with 25 participants per cluster achieved at least 80% power to detect a difference of 7.3 mm Hg SBP between the group means when the standard deviation was 12.1 mm Hg. Allowing for an attrition rate of 10%, we would require 27 participants per cluster.

Statistical analysis will be performed using Statistical Package for Social Science (SPSS) version 23 and STATA software version 14. To test the effectiveness of the intervention on the primary and secondary outcomes, a multivariate multilevel mixed-effects linear regression model will be used to analyze outcomes. This is due to the hierarchical structure of the data and based on the consideration of the correlations between participants’ repeated measurements over time. Because the participants are nested within hospital wards, we will fit a three-level mixed model with random intercepts at both the cluster and the participant-within-cluster levels. Thus, models will account for the clustering in wards, participants within clusters and over time using mixed command. Wards and participants within wards will be treated as random effects. The main effects will be group (intervention or comparison), time (baseline, three and six months) and group x time interaction. A small-sample correction to the restricted maximum likelihood estimator will be used to improve the inference for the fixed parameters and is available in STATA mixed command. Models will be adjusted by baseline value and confounders that include age, gender, body mass index (BMI), duration of hypertension, duration of diabetes, smoking status and education level. A univariate model will also be used for unadjusted estimates. The level of significance will be set at p<0.05. Where appropriate, 95% confidence intervals (95% CIs) will be reported along with p-values.

Data analysis will be performed according to the intention-to-treat principle. Participants who withdraw or do not complete the six months follow-up will be included in the analysis. Multiple imputation technique will be used for large missing data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/06/2017
Date of last participant enrolment
Anticipated
1/11/2017
Actual
30/11/2017
Date of last data collection
Anticipated
30/06/2018
Actual
30/06/2018
Sample size
Target
270
Accrual to date
Final
270
Recruitment outside Australia
Country [1] 9031 0
China
State/province [1] 9031 0
Nanchang, Jiangxi

Funding & Sponsors
Funding source category [1] 296862 0
University
Name [1] 296862 0
Research student maintenance funding of Flinders University.
Country [1] 296862 0
Australia
Primary sponsor type
University
Name
Flinders University of Australia
Address
College of Nursing and Health Sciences, Flinders University, Sturt Road, Bedford Park, SA 5042, Australia
Country
Australia
Secondary sponsor category [1] 295876 0
Government body
Name [1] 295876 0
Department of Scientific Research Management at Health and Family Planning Commission of Jiangxi Province, China.
Address [1] 295876 0
Department of Scientific Research Management at Health and Family Planning Commission of Jiangxi Province, China,
NO. 2 West Road, Sheng Zheng Fu Da Yuan,
Nanchang, Jiangxi, China
Country [1] 295876 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298088 0
The Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 298088 0
Ethics committee country [1] 298088 0
Australia
Date submitted for ethics approval [1] 298088 0
23/08/2016
Approval date [1] 298088 0
30/11/2016
Ethics approval number [1] 298088 0
OFR#345.16-HREC/16/SAC/308

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2066 2066 0 0
/AnzctrAttachments/372119(v20-09-2017-15-15-16)-345.16 General Research Approval Letter.pdf (Ethics approval)
Attachments [2] 2067 2067 0 0
/AnzctrAttachments/372119-Additional file 1_ Intervention diary- patient version - Copy.docx (Other)
Attachments [3] 2069 2069 0 0
/AnzctrAttachments/372119-Additional file 2_ Intervention record-community nurse and GPversion - Copy.docx (Other)

Contacts
Principal investigator
Name 71534 0
A/Prof Lily Xiao
Address 71534 0
College of Nursing and Health Sciences
Flinders University
Sturt Road, Bedford Park
GPO BOX 2100, Adelaide
South Australia 5042
Country 71534 0
Australia
Phone 71534 0
+618 8201 3419
Fax 71534 0
+618 8276 1602
Email 71534 0
lily.xiao@flinders.edu.au
Contact person for public queries
Name 71535 0
Lily Xiao
Address 71535 0
College of Nursing and Health Sciences
Flinders University
Sturt Road, Bedford Park
GPO BOX 2100, Adelaide
South Australia 5042
Country 71535 0
Australia
Phone 71535 0
+618 8201 3419
Fax 71535 0
+618 8276 1602
Email 71535 0
lily.xiao@flinders.edu.au
Contact person for scientific queries
Name 71536 0
Lily Xiao
Address 71536 0
College of Nursing and Health Sciences
Flinders University
Sturt Road, Bedford Park
GPO BOX 2100, Adelaide
South Australia 5042
Country 71536 0
Australia
Phone 71536 0
+618 8201 3419
Fax 71536 0
+618 8276 1602
Email 71536 0
lily.xiao@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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
SourceTitleYear of PublicationDOI
EmbaseHypertension management for community-dwelling older people with diabetes in Nanchang, China: Study protocol for a cluster randomized controlled trial.2018https://dx.doi.org/10.1186/s13063-018-2766-5
N.B. These documents automatically identified may not have been verified by the study sponsor.