Home-Based Intervention to the Diabetics

NCT04104711 | Completed DMC

• 1 other identifier: 970-GOA, 2014 / 07-20
• Study Type: interventional
• Target: 81
• Locations: 0 countries
• Sites: N/A

Brief Summary

Why is the research needed?

• This study reflects the complexity of the process that patients with diabetes are experiencing when staying at home away from the supervision of health professionals. In this context, there is a gap in the literature on home care of diabetes.
• The barriers, facilitators and the other perceptions that affect each diabetic's compliance with the disease-related recommendation are different. Nurses need to be aware of this.
• For this reason, according to the Health Belief Model, an original study was conducted to evaluate the nursing intervention program's results on patient care and cost-effectiveness in a home for supporting self-management of diabetic patients. Hypotheses of the Study Patients with diabetes undergoing home-based nursing interventions in line with the Health Belief Model. H1: have higher mean scores for the Health Belief Model Scale than the control group. H2: have higher mean scores for the Self-Efficacy Scale than the control group. H3: have lower HbA1c levels than the control group. H4: have lower blood glucose levels (BGL) than the control group. H5: have lower blood pressure levels than the control group. H6: have lower BMI levels than the control group. H7: have fewer hospital admissions due to an acute or chronic complication than the control group. H8: have a lower complication-related cost rate than the control group.

Conditions

Diabetes Mellitus, Type 2; Home Visit

Keywords

Diabetes; public health nursing; randomized controlled trials; chronic illness; Health Belief Model

Outcome Measures

Primary Outcomes (8)

• Health Belief Model Scale in Patients with Diabetes

  The Health Belief Model Scale was developed in China, the validity and reliability study of the Turkish version of the scale was conducted in 2007 and the Cronbach's alpha value was 0.72 and 0.90 respectively. The subscales of the scale were as follows: perceived Susceptibility (5 items), Perceived Severity (3 items), Perceived Benefits (7 items), Perceived Barriers (11 items) and Recommended health-related activities (10 items). The items of the scale are evaluated in a 5-point Likert scale, from 1 (I strongly disagree) to 5 (I strongly agree). Every subscale mean isdetermined by dividing the total points of all thesubscale items by the total number of items. The total scale score mean is calculated by dividing the totalpoints of all the items by the total number of items. A positive health belief of 4 points and above; a score below 4 is interpreted as a negative health belief.

  6 month

• Diabetes Management Self-Efficacy Scale for Patients with Type 2 Diabetes

  Diabetes Management Self-Efficacy Scale was developed in 1999, the validity and reliability study of the Turkish version of the scale was conducted in 2001. The Cronbach's alpha value was 0.89 for both versions .The scale has 4 subscales: nutrition specific and weight, physical exercise, and blood sugar, nutrition general and medical treatment. The tool has 20 items. The items are in a 5-point Likert scale from 1 (absolutely no) to 5 (absolutely yes).The lowest possible score from the scale is 20, the highest is 100.

  6 month

• Fasting plasma glucose level (mg/dl)

  The mean of plasma glucose level (milligram / deciliter) was used to compare patients' diabetic control and evaluate pre- and post-intervention values in the study process.

  6 month

• Postprandial glucose level (mg/dl)

  The mean of postprandial glucose level (milligram / deciliter) was used to compare patients' diabetic control and evaluate pre- and post-intervention values in the study process.

  6 month

• Hemoglobin A1c level (%)

  The mean of Hemoglobin A1c level (per cent) was used to compare patients' diabetic control by 3 months period and evaluate pre- and post-intervention values in the study process.

  6 month

• Body mass index (kg/m2)

  Body mass index is important for metabolic control of diabetic patients. For this outcome weight and height of patients were measured. Then body mass index was calculated by the formula (weight (kilogram) / height (meter) x height (meter)). Body mass index were recorded kilogram/meter2.

  6 month

• Blood pressure level (mmHg)

  Blood pressure levels were recorded milimeters mercury. Systolic and Diastolic Blood Pressure levels were measured both. This outcome is essential for macrovasculer complications.

  6 month

• Costs via frequency of complication-related hospital admissions

  To calculate the cost of hospitalization for each patient, consumables (blood glucose measuring equipment, wound care products, wound cover, sterile gloves, catheter, urine bag, pen needle, infusion pump set) and time spent by the nurse (30 minutes for each patient) were determined. The cost of the time spent by the nurse was based on a new graduate nurse's salary and was calculated by using the formula '' salary ($)/ working time of May 2017 x 0.5 hours''.

  6 month

Other Outcomes (1)

• Sociodemographic and disease-related characteristics of patients with diabetes

  First month

Study Arms (2)

Home visits+Health education group

EXPERIMENTAL

Home visits were paid 3 times at 3-month intervals. After the home visits started, reminder messages supporting the home visit process were sent at two-week intervals. Nursing interventions were applied in accordance with the subscales of the Health Belief Model by taking into account the individual differences of the participants and were performed within the scope of the basic dimensions of diabetes management such as nutrition, exercise, medication management, oral care and foot care. In addition, the importance of annual monitoring of HBA1c, blood lipid, albumin/ creatinine levels, fundus examination, blood pressure monitoring, sleep hygiene, avoidance of smoking and alcohol was also explained.

Other: Home visits, health education

No nursing intervention group

NO INTERVENTION

The participants in the control group who have standart care by other health services were contacted 3 times at 3-month intervals through telephone calls, and were applied the data collection tools only. They have no nursing intervention by the researcher. At the end of the study, for ethical statement the participants in the control group were given health training and the training booklet was distributed to them.

Interventions

Home visits, health education OTHER

Home visits+Health education group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteering to participate in the study
• Having Type 2 diabetes
• Not having diabetes-related complications
• Having a mobile phone to contact any time
• Living in the districts of Balçova, Narlıdere and Güzelbahçe

You may not qualify if:

• Having Type I diabetes
• Having been involved in a home care program previously
• Being illiterate in Turkish
• Having disabilities preventing the person from understanding others

Sponsors & Collaborators

• Dilay AÇIL,PhD: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Chronic Disease

Interventions

House Calls

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Dilay AÇIL, Asst.Prof.

  Manisa Celal Bayar University

  PRINCIPAL INVESTIGATOR

• Zuhal BAHAR, Prof.

  Koç University

  STUDY DIRECTOR

• Abdurrahman ÇÖMLEKÇİ, MD,Prof.

  Dokuz Eylul University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: During the first home visit, the participants in the intervention group were applied the data collection tools, and then nursing interventions in accordance with the subscales of the Health Belief Model by taking into account the individual differences of the participants. The nursing interventions were performed within the scope of the basic dimensions of diabetes management such as nutrition, exercise, medication management, etc. was also explained. Home visits were paid 3 times at 3-month intervals. After the home visits started, reminder messages supporting the home visit process were sent at two-week intervals. The participants in the control group were contacted 3 times at 3-month intervals through telephone calls, and were applied the data collection tools. At the end of the study, the participants in the control group were given health training and booklet was distributed to them.

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 26, 2019
• Study Start: January 1, 2015
• Primary Completion: March 30, 2017
• Study Completion: July 14, 2017
• Last Updated: September 30, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share