Diabetes MellitusNCT01387633
Educational Intervention and Social Support in Diabetes Mellitus
A study testing Educational intervention for family members/caregivers of people with diabetes mellitus through telephone contact and Educational intervention group for people with diabetes through Diabetes Conversation Maps in people with Diabetes Mellitus, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the impact of an educational program for people with diabetes mellitus based on the family social support. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Educational intervention for family members/caregivers of people with diabetes mellitus through telephone contact and Educational intervention group for people with diabetes through Diabetes Conversation Maps
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2011to Jun 2011
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with DM2
- Both sexes
- Minimum age of 40 years
- Able to dialogue
- Lack of complications in advanced
Who cannot join
- Hemodialysis treatment
- Amaurosis
- Sequelae of Stroke and/or Heart Failure
- Previous amputations at any level of the lower limb
- Active ulcer in the lower limbs
- People in wheelchairs and/or litter
- People with limited understanding of the instruments due to cultural factors
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, 14048-900
Ana Emilia Pace, Principal Investigator, (55) 16 3602-3401, aepace@eerp.usp.br
Ana Emilia Pace, Principal Investigator
About this study
The purpose of this study is to evaluate the impact of an educational program for people with diabetes mellitus based on the family social support.
Read the detailed description
H0: The person with diabetes who participates in the educational group whose family member/caregiver receives educational interventions hasn't greater glycemic control.
HA: The person with diabetes who participates in the educational group whose family member/caregiver receives educational interventions has greater glycemic control.
- Conditions
- Diabetes Mellitus
- Being tested
- Educational intervention for family members/caregivers of people with diabetes mellitus through telephone contact, Educational intervention group for people with diabetes through Diabetes Conversation Maps
- Keywords
- Nursing care, Diabetes mellitus, Health Education, Patient compliance, Social support, Self-efficacy, Adaptation strategy
- Medical subject headings
- Diabetes Mellitus, Health Education, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational intervention for family members/caregivers of people with diabetes mellitus through telephone contactOther
For family members/caregivers: telephone contacts will be conducted in day and time which family member/caregiver prefers, and he/she may make collect calls to the researcher always he/she judges it necessary during the period of study. Phone contacts will be recorded to ensure the registration of orientation given, using a digital phone recorder PCTEL. And they will be arranged with the technique of motivational interviewing that includes the skills to ask, listen and inform. For this, protocols based on these skills, which the covered topics will be those worked in group sessions through Diabetes Conversation Maps. Voice quality related to the tone, volume and clarity as well as the skills and strategies to listen to the interviews will be worked under the guidance of an audiologist
Educational intervention group for people with diabetes through Diabetes Conversation MapsOther
For people with diabetes mellitus: educational interventions will be conducted in accordance with the assumptions of the Social Cognitive Theory, through Diabetes Conversation Maps , whose use is consistent with this theory (ADA, 2007). Diabetes Conversation Maps are a tool which involves people in the learning process about the disease, to make them able to process information more effectively and use them in making daily decisions in the management of diabetes mellitus (DM). It is recommended that this tool is used in small groups of three to ten people, in order to provide dynamic discussions among the participants (ADA, 2007). Currently, the maps that cover the following learning contexts: How the Body and Diabetes Work, Healthy Eating and Physical Activity, and Medication Treatment and Monitoring of Blood Glucose; Achieving the Goals with the Insulin and Weather Map of Diabetic Foot are available for the Brazilian Portuguese language.
| Study group | Role | What they receive |
|---|---|---|
| Educational intervention through telephone contact | Experimental | Educational intervention for family members/caregivers of people with diabetes mellitus through telephone contact Receives: Other: Educational intervention for family members/caregivers of people with diabetes mellitus through telephone contact |
| Educational intervention group | Active comparator | Educational intervention group for people with diabetes through Diabetes Conversation Maps. Receives: Other: Educational intervention group for people with diabetes through Diabetes Conversation Maps |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycated hemoglobin
Measured: 21 mounths
fasting plasma glucose
Measured: 21 mounths
triglycerides
Measured: 21 mounths
total cholesterol and fractions
Measured: 21 mounths
microalbuminuria
Measured: 21 mounths
urea
Measured: 21 mounths
creatinine
Measured: 21 mounths
body mass index
Measured: 21 mounths
waist circumference
Measured: 21 mounths
blood pressure
Measured: 21 mounths
Secondary outcomes (9)
Perceived Self-Efficacy: Diabetes Management Self-efficacy Scale for Patients with Type 2 Diabetes Mellitus
Measured: 21 mounths
Knowledge about diabetes mellitus: Diabetes Mellitus knowledge (DKN-A)
Measured: 21 mounths
Adherence to medication treatment: Self-Reported Measure of Medication Adherence (Measure of Treatment Adherence - MTA)
Measured: 21 mounths
Adherence to self care: Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) ( Diabetes Self-Care Activities Questionnaire)
Measured: 21 mounths
Perception of stress: Perceived Stress Scale (Perceived Stress Scale)
Measured: 21 mounths
Ways of coping: Ways of Coping Scale (Ways of Coping Scale)
Measured: 21 mounths
Acceptance of Illness (Acceptance of Illness Scale)
Measured: 21 mounths
Perception of social support: The Social Support Network Inventory
Measured: 21 mounths
Self-monitoring of blood glucose
Measured: 21 mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387633
- Sponsor's protocol ID
- diabetes2011
- Status last verified
- Feb 2010
- First submitted
- 16 Jun 2011
- Last updated
- 4 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Intervention and Social Support in Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01387633
- Acronym / sponsor ID
- diabetes2011
- Conditions
- Diabetes Mellitus
- Keywords
- Nursing care, Diabetes mellitus, Health Education, Patient compliance, Social support, Self-efficacy, Adaptation strategy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2011 (actual)
- First posted
- 4 Jul 2011 (estimated)
- 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.
The purpose of this study is to evaluate the impact of an educational program for people with diabetes mellitus based on the family social support.
Detailed description
H0: The person with diabetes who participates in the educational group whose family member/caregiver receives educational interventions hasn't greater glycemic control.
HA: The person with diabetes who participates in the educational group whose family member/caregiver receives educational interventions has greater glycemic control.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational intervention through telephone contact | Experimental | Other: Educational intervention for family members/caregivers of people with diabetes mellitus through telephone contactEducational intervention for family members/caregivers of people with diabetes mellitus through telephone contact |
| Educational intervention group | Active comparator | Other: Educational intervention group for people with diabetes through Diabetes Conversation MapsEducational intervention group for people with diabetes through Diabetes Conversation Maps. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- People with DM2
- Both sexes
- Minimum age of 40 years
- Able to dialogue
- Lack of complications in advanced
Key exclusion criteria (7 listed)
- Hemodialysis treatment
- Amaurosis
- Sequelae of Stroke and/or Heart Failure
- Previous amputations at any level of the lower limb
- Active ulcer in the lower limbs
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 |
|---|---|---|
| Educational intervention for family members/caregivers of people with diabetes mellitus through telephone contactFor family members/caregivers: telephone contacts will be conducted in day and time which family member/caregiver prefers, and he/she may make collect calls to the researcher always he/she judges it necessary during the period of study. Phone contacts will be recorded to ensure the registration of orientation given, using a digital phone recorder PCTEL. And they will be arranged with the technique of motivational interviewing that includes the skills to ask, listen and inform. For this, protocols based on these skills, which the covered topics will be those worked in group sessions through Diabetes Conversation Maps. Voice quality related to the tone, volume and clarity as well as the skills and strategies to listen to the interviews will be worked under the guidance of an audiologist | Other | Educational intervention through telephone contact |
| Educational intervention group for people with diabetes through Diabetes Conversation MapsFor people with diabetes mellitus: educational interventions will be conducted in accordance with the assumptions of the Social Cognitive Theory, through Diabetes Conversation Maps , whose use is consistent with this theory (ADA, 2007). Diabetes Conversation Maps are a tool which involves people in the learning process about the disease, to make them able to process information more effectively and use them in making daily decisions in the management of diabetes mellitus (DM). It is recommended that this tool is used in small groups of three to ten people, in order to provide dynamic discussions among the participants (ADA, 2007). Currently, the maps that cover the following learning contexts: How the Body and Diabetes Work, Healthy Eating and Physical Activity, and Medication Treatment and Monitoring of Blood Glucose; Achieving the Goals with the Insulin and Weather Map of Diabetic Foot are available for the Brazilian Portuguese language. | Other | Educational intervention group |
Primary outcome
glycated hemoglobin
Time frame: 21 mounths
fasting plasma glucose
Time frame: 21 mounths
triglycerides
Time frame: 21 mounths
total cholesterol and fractions
Time frame: 21 mounths
microalbuminuria
Time frame: 21 mounths
urea
Time frame: 21 mounths
creatinine
Time frame: 21 mounths
body mass index
Time frame: 21 mounths
waist circumference
Time frame: 21 mounths
blood pressure
Time frame: 21 mounths
9 secondary outcomes
Perceived Self-Efficacy: Diabetes Management Self-efficacy Scale for Patients with Type 2 Diabetes Mellitus
Time frame: 21 mounths
Knowledge about diabetes mellitus: Diabetes Mellitus knowledge (DKN-A)
Time frame: 21 mounths
Adherence to medication treatment: Self-Reported Measure of Medication Adherence (Measure of Treatment Adherence - MTA)
Time frame: 21 mounths
Adherence to self care: Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) ( Diabetes Self-Care Activities Questionnaire)
Time frame: 21 mounths
Perception of stress: Perceived Stress Scale (Perceived Stress Scale)
Time frame: 21 mounths
Ways of coping: Ways of Coping Scale (Ways of Coping Scale)
Time frame: 21 mounths
Acceptance of Illness (Acceptance of Illness Scale)
Time frame: 21 mounths
Perception of social support: The Social Support Network Inventory
Time frame: 21 mounths
Self-monitoring of blood glucose
Time frame: 21 mounths
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2011.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention for family members/caregivers of people with diabetes mellitus through telephone contact and Educational intervention group for people with diabetes through Diabetes Conversation Maps in people with Diabetes Mellitus, run by University of Sao Paulo at 1 site in Brazil.
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 7 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: status not confirmed, as of the sponsor's last update on 4 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Emilia Pace, Principal Investigator ((55) 16 3603-3401, aepace@eerp.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycated hemoglobin (time frame: 21 mounths). The study lists 10 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 4 Jul 2011.