Demographic, Clinical, and Biomedical Profile of Diabetic Patients Receiving Home Healthcare in Saudi Arabia

July 5, 2023 updated by: Lamya Mohammed Alzubaidi, Saudi Scientific Home Health Care Society

Background: Identifying characteristics of diabetic patients receiving home healthcare will help in designing services that respond to their conditions and improve their health status and quality of life. The aim of this study is to describe demographic, clinical, and biomedical characteristics of diabetic patients receiving home healthcare.

Methodology:

Descriptive cross-sectional study was conducted in King Salman Hospital in Riyadh, and Al Madinah home healthcare center in Saudi Arabia. The study Population included diabetic patients receiving home healthcare from these two health institutions. The inclusion criteria were type 1 and type 2 diabetes mellitus, all age groups, both males and females. A sample of 239 diabetic patients was selected using the stratified random sampling technique. Data were collected from the medical records of the eligible, selected study population using a structured data collection sheet. Data were analysed by statistical Package for the Social Sciences (SPSS) version 21. Categorical data were expressed as percentages with 95% confidence intervals, continuous data as mean and standard deviations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background:

Diabetes Mellitus (DM) is a chronic disease that affects approximately 194 million individuals, equivalent to 5.1% of the adult population globally1. In Saudi Arabia, the age-adjusted prevalence of diabetes is currently estimated to be 18.7% according to the International Diabetes Federation2. This high prevalence places the country among the top five in the Middle East and North Africa region 2 and top ten globally3.

DM can cause acute medical crises, such as diabetic ketoacidosis4, as well as long-term complications, including blindness, renal failure, and lower limb amputations1. These complications can cause significant suffering for individuals and have a considerable impact on their quality of life and overall health outcomes1,4.

To effectively prevent medical crises and long-term complications associated with diabetes, access to ongoing and timely care is crucial, and flexible follow-up schedules must also be in place to ensure comprehensive management of the disease4,5. However, the access and scheduling limitations associated with traditional clinic-based medical care might hinder the provision of such care5. Consequently, home-based care has emerged as a convenient alternative for the provision of diabetes management, particularly for elderly individuals and patients who are house-bound or bed-dependent.

Home healthcare (HHC) is a recognized model of healthcare provision that encompasses a broad range of medical and health services delivered by skilled practitioners in the patient's home6-7. DM is currently located behind congestive heart failure as the primary diagnosis for admission to HHC7,8. In Saudi Arabia, patients with diabetes mellitus are among the seventeen categories that qualify for HHC services provided by the Ministry of Health(MoH)9.

Numerous studies have evaluated the characteristics of diabetic patients in Saudi Arabia, including their glycaemic control levels3,10,11. However, there is a lack of data regarding diabetic patients who receive HHC. These patients may differ from the general diabetic population, as they may be older and experience mobility restrictions due to underlying conditions. Consequently, there is a pressing need to identify the profile of these patients to determine their current situation and to inform the development of tailored HHC services that enhance their health outcomes and overall quality of life.

  1. Objective:

2.1. General Objective To assess the Current situation of diabetic patients receiving Home Health Care in Riyadh and Medina Regions 2.2. Specific Objectives:

  1. To identify the characteristics of diabetic patients receiving Home Health Care in Riyadh and Medina Regions with regards to:

    • General background
    • Medical and biomedical
    • Use of outpatient services
    • Admission to hospital

  2. To describe the home healthcare provided to diabetic patients in Riyadh and Medina Regions with regards to:

    • Types of services
    • Type of home healthcare provider

2. Material and methods: 2.3. Study design: Descriptive cross-sectional study 2.4. Study area: 3. Study was conducted in the King Salman Hospital and Al Madinah Home Healthcare center. King Salman hospital was the first hospital to start the provision of homecare services in Riyadh region in 2005. Currently the hospital has 390 patients receiving home healthcare, around 50% of them have DM. Al Madinah Home Healthcare center was also established in 2005 and currently provides care to 581 patients, with approximately 86% of them diagnosed with DM. The scope of the services provided under the home healthcare in both centers covers diagnosis, management and follow-up of patients. Both HHC centers belong to the Saudi MoH and provide HHC services according to the regulations of the General Directorate of HHC in the MoH.

3.1. Study population: Diabetic patients receiving home healthcare by King Salman Hospital and Al Madinah Home healthcare center.

o Inclusion criteria:

  • Type1 and type 2 diabetes mellitus
  • All age groups

  • Males and females 3.2. Sampling: • Sampling technique: The sample was selected using the stratified random sampling technique. The calculated sample size was divided between the King Salman homecare centre and Al Madinah homecare centre according to the weight of diabetic patients in each centre. From each centre the diabetic patients were selected using the simple random sampling technique.

    • Sample size:

Population size(for finite population correction factor or fpc)(N): 630 Hypothesized % frequency of outcome factor in the population (p): 50%+/-5 Confidence limits as % of 100(absolute +/- %)(d): 5% Confidence level 95%

The sample was calculated using the calculator of the Open Source Statistics for Public Health [13] assuming the following inputs:

This this yielded a sample size of 239 diabetic patients.

3.3. Data collection technique and tool: 3.3.1. Source of data:

  • Medical records of diabetic patients receiving home health care from King Salman hospital in Riyadh and Al Madinah Home healthcare center in Al Madinah.

  • Data were collected a structured, per-coded data collection sheet composed of the following sections:

    • General background information:

      • Sociodemographic characteristics (age, gender…. etc.)
      • Presence of care giver
      • Knowledge of caregiver

    • Medical information:

      • Type of diabetes
      • Medication
      • Duration of diabetes
      • Co-morbidities
      • Diabetes complications
      • Admission to hospital
      • Use of outpatient services

    • Biomedical information:

      • Blood pressure
      • Weight, height (BMI)
      • Glycated hemoglobin.
      • Fasting blood glucose (FBG),
      • Serum creatinine

    • Home healthcare

      • The types of homecare health services received
      • Type of healthcare professional providing the home healthcare
      • The frequency of the home healthcare per week/month
      • The duration of the home healthcare 3.4. Data analysis plan: Data entry and analysis were performed using Statistical Package for the Social Sciences software version 21. The data were summarized and presented as frequencies and percentages for categorical data, and means (± standard deviation) for normally distributed numerical data, and medians (range) for skewed numerical data. Using the HbA1c values, the study population was divided into two categories (HbA1c <8% and HBA1c ≥8%) according to The Saudi National Diabetes Center (SNDC) guidelines for elderly diabetic patients with comorbidities. The eGFR was calculated using age, sex, ethnicity and creatinine level, and the population was grouped based on SNDC guidelines as eGFR <60 or ≥60 mL/min/1.73m2.

3.5. Ethical considerations: The research was considered exempt from review by the Institutional Review Board (IRB) of Prince Nourah bint Abdulrahman University ( IRB log number:22-1051).

Study Type

Observational

Enrollment (Actual)

252

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Al Madinah, Saudi Arabia, 42210
        • Al Madinah Home Healthcare center
      • Riyadh, Saudi Arabia, 12769
        • King Salman Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients diagnosed with diabetes milletus receiving home healthcare from King Salman Hospital in Riyadh and Al Madinah Home healthcare center in Al Madinah, Saudi Arabia

Description

Inclusion Criteria:

  • Type1 and type 2 diabetes mellitus
  • All age groups
  • Males and females
  • Receiving home healthcare

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomedical profile of diabetic patients
Time Frame: three months
proportion of diabetic patients with Glycated haemoglobin less than 8%
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saudi Scientific Home Health Care Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2022

Primary Completion (Actual)

February 15, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

June 14, 2023

First Submitted That Met QC Criteria

June 23, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

July 5, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 01 (Miami VAHS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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