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A hypertension management program for community-dwelling older people with diabetes in China

The effect of a hypertension management program on blood pressure in community-dwelling older people with diabetes: A cluster randomized controlled trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001352392
Enrollment
270
Registered
2017-09-26
Start date
2017-06-15
Completion date
2017-11-30
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

In China, the primary care system such as Community Health Service Center is underdeveloped. Patients with chronic diseases usually choose tertiary and secondary hospitals when seeking treatment. As a consequence, tertiary and secondary hospitals are overwhelmed with the patients. This situation is worsened by lack of collaboration and communication between hospitals and Community Health Service Centers. The demand of managing hypertension in primary care settings through comprehensive strategies is largely overlooked. Establishing collaboration between hospital and Community Health Service Center is of paramount importance for alleviating this imbalance. The study intervention emphasises collaborative care among health professionals within and between hospitals and Community Health Service Centers in Nanchang, China in managing hypertension for older people with diabetes. The aim of this study is to test a hypothesis that a hypertension management program built on collaboration between hospitals and Community Health Service Centers can improve blood pressure control in old people with diabetes.

Interventions

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). Heal

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.

Sponsors

Flinders University of Australia
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 23, 2026