Diabetes Mellitus, Type 2NCT04104711
Home-Based Intervention to the Diabetics
A study testing Home visits, health education in people with Diabetes Mellitus, Type 2 and Home Visit, run by Dilay AÇIL,PhD.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Home Visit
- What is being tested?
- Home visits, health education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 14 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: The Outcomes of Home-Based Intervention to the Diabetics According to the Health Belief Model: A Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
Type of the study The study was conducted as an intervention (randomized controlled, single-blind) one.
Location and Time of the Study The study was carried out between January 2015 and March 2017 in three districts of İzmir, a province in the western part of Turkey.
The study population and sample While the patients with diabetes living in districts comprised the study population, the sample was selected from patients with type II diabetes registered to Family Health Centers.
According to the Consolidated Standards of Reporting Trials (CONSORT) recommended for randomized controlled studies, a randomization flow chart was established, and 2460 people with diabetes were assessed for compliance with diabetes. From the 1081 people with diabetes who met the inclusion criteria, the intervention, and control groups each to include 65 individuals were constructed using the "Research Randomizer" computer program. The study was completed with 81 people with diabetes (42 in the intervention group and 39 in the control group). Post hoc power analysis was performed using the G-Power Data Analysis program and the power of the study was determined as 100% at the 95% confidence interval and p = .05 significance level.
The participants were not told to which group they were assigned. Thus, the study was conducted as a single-blind study.
Training Booklet and Implementation Steps A booklet including information on nursing interventions for diabetes was prepared. The training booklet was based on the current literature and the results of the qualitative study conducted on the issue in the first step of the Ph.D. thesis. The booklet was revised in line with the opinions obtained from 5 professors who were experts in the field. The International Standard Book Number (978-975-441-462-2 ISBN) for the booklet was obtained by the Presidency of Dokuz Eylül University and published in the Dokuz Eylül University Press.
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, 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. 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 at the Dokuz Eylül University Faculty of Nursing and the training booklet was distributed to them.
Analysis of the Data The study data were analyzed using numbers, percentages, the chi-square test, the test for the Significance of the Difference Between Two Means, the Repeated Measures Multivariate Analysis of Variance, Bonferroni-adjusted t-test independent groups and multiple regression analysis in the Statistical Package for Social Sciences (SPSS) (23.0) program.
- Conditions
- Diabetes Mellitus, Type 2, Home Visit
- Being tested
- Home visits, health education
- Keywords
- Diabetes, public health nursing, randomized controlled trials, chronic illness, Health Belief Model
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home visits, health educationOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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''.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start1 Jan 2015
- Primary completion30 Mar 2017
- Study completion14 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dilay AÇIL,PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dilay AÇIL,PhD, Dokuz Eylul University
- Investigators
- Dilay AÇIL, Asst.Prof., Principal investigator, Manisa Celal Bayar UniversityZuhal BAHAR, Prof., Study director, Koç UniversityAbdurrahman ÇÖMLEKÇİ, MD,Prof., Study chair, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104711
- Sponsor's protocol ID
- 970-GOA, 2014 / 07-20
- Status last verified
- Sep 2019
- First submitted
- 16 Sep 2019
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcomes of Home-Based Intervention to the Diabetics According to the Health Belief Model: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04104711
- Acronym / sponsor ID
- 970-GOA, 2014 / 07-20
- Conditions
- Diabetes Mellitus, Type 2, Home Visit
- Keywords
- Diabetes, public health nursing, randomized controlled trials, chronic illness, Health Belief Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Dilay AÇIL,PhDUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 14 Jul 2017 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Type of the study The study was conducted as an intervention (randomized controlled, single-blind) one.
Location and Time of the Study The study was carried out between January 2015 and March 2017 in three districts of İzmir, a province in the western part of Turkey.
The study population and sample While the patients with diabetes living in districts comprised the study population, the sample was selected from patients with type II diabetes registered to Family Health Centers.
According to the Consolidated Standards of Reporting Trials (CONSORT) recommended for randomized controlled studies, a randomization flow chart was established, and 2460 people with diabetes were assessed for compliance with diabetes. From the 1081 people with diabetes who met the inclusion criteria, the intervention, and control groups each to include 65 individuals were constructed using the "Research Randomizer" computer program. The study was completed with 81 people with diabetes (42 in the intervention group and 39 in the control group). Post hoc power analysis was performed using the G-Power Data Analysis program and the power of the study was determined as 100% at the 95% confidence interval and p = .05 significance level.
The participants were not told to which group they were assigned. Thus, the study was conducted as a single-blind study.
Training Booklet and Implementation Steps A booklet including information on nursing interventions for diabetes was prepared. The training booklet was based on the current literature and the results of the qualitative study conducted on the issue in the first step of the Ph.D. thesis. The booklet was revised in line with the opinions obtained from 5 professors who were experts in the field. The International Standard Book Number (978-975-441-462-2 ISBN) for the booklet was obtained by the Presidency of Dokuz Eylül University and published in the Dokuz Eylül University Press.
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, 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. 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 at the Dokuz Eylül University Faculty of Nursing and the training booklet was distributed to them.
Analysis of the Data The study data were analyzed using numbers, percentages, the chi-square test, the test for the Significance of the Difference Between Two Means, the Repeated Measures Multivariate Analysis of Variance, Bonferroni-adjusted t-test independent groups and multiple regression analysis in the Statistical Package for Social Sciences (SPSS) (23.0) program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Home visits+Health education group | Experimental | Other: Home visits, health educationHome 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home visits, health education | Other | Home visits+Health education group |
Primary outcome
Health Belief Model Scale in Patients with Diabetes
Time frame: 6 month
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.
Diabetes Management Self-Efficacy Scale for Patients with Type 2 Diabetes
Time frame: 6 month
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.
Fasting plasma glucose level (mg/dl)
Time frame: 6 month
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.
Postprandial glucose level (mg/dl)
Time frame: 6 month
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.
Hemoglobin A1c level (%)
Time frame: 6 month
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.
Body mass index (kg/m2)
Time frame: 6 month
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.
Blood pressure level (mmHg)
Time frame: 6 month
Blood pressure levels were recorded milimeters mercury. Systolic and Diastolic Blood Pressure levels were measured both. This outcome is essential for macrovasculer complications.
Costs via frequency of complication-related hospital admissions
Time frame: 6 month
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''.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilay AÇIL, Asst.Prof. principal investigator
Manisa Celal Bayar University
Zuhal BAHAR, Prof. study director
Koç University
Abdurrahman ÇÖMLEKÇİ, MD,Prof. study chair
Dokuz Eylul University
Questions about this trial
What is this clinical trial studying?
A study testing Home visits, health education in people with Diabetes Mellitus, Type 2 and Home Visit, run by Dilay AÇIL,PhD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Belief Model Scale in Patients with Diabetes (time frame: 6 month). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.