Type 2 DiabetesNCT05491252
A Randomized Controlled Trial of Patient-Centered Self-Management Intervention in Adults With Type 2 Diabetes Mellitus
A study testing PAtient CEntered Self-Management Intervention (PACE-SMI) in people with Type 2 Diabetes, run by Shifa Tameer-e-Millat University at 4 sites in Pakistan.
Trial summary
Type 2 Diabetes Mellitus (DM) is a serious health problem for Pakistan and around the world due to its increasing prevalence and the risk of adverse health outcomes including kidney failure, heart attack, stroke, leg amputation and blindness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- PAtient CEntered Self-Management Intervention (PACE-SMI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 612 participants
- Where
- 4 sitesPakistan
- Study dates
- 21 Apr 2022to 17 Feb 2023
- 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
- Adult (aged 18 years or above)
- Diagnosed with type 2 Diabetes Mellitus for at least 06 months duration.
- Willing to participate in the study by signing of the consent form.
Who cannot join
- Type 2 DM Patient with HbA1c < 7
- Uncontrolled psychological comorbidity (psychosis, schizophrenia, dementia or severe learning difficulties).
- Severe comorbidity that may limit participation (medical conditions such as cancer, stroke with disabilities, or need for regular dialysis etc. that preclude complete participation in this study).
- Life expectancy of less than six months as determined by patient's primary physician.
- Living outside of Faisalabad City.
Trial locations and contacts
4 sites in 1 country.
Pakistan4 sites
District Head Quarter (DHQ) Hospital
Faisalabad, Punjab Province, 38000
Allied Hospital
Faisalābad, Punjab Province, 38000
Government General Hospital
Faisalābad, Punjab Province, 38000
Punjab Social Security Hospital
Faisalābad, Punjab Province, 38000
About this study
Official title: A Patient-Centered Self-Management Intervention to Improve Glycemic Control, Self-Efficacy and Self-Care Behaviors in Adults With Type 2 Diabetes Mellitus: Randomized Controlled Trial
Type 2 Diabetes Mellitus (DM) is a serious health problem for Pakistan and around the world due to its increasing prevalence and the risk of adverse health outcomes including kidney failure, heart attack, stroke, leg amputation and blindness. These problems reduce the quality of life of individuals with type 2 DM and increase their financial burden, thereby affecting the national economy. Given its huge health and economic impact, preventing type 2 DM progression and reducing the risk of associated complications requires immediate attention. Evidence suggests that self-management can slow the progression of type 2 DM, minimizes the risk of major complications and hence, lowers health-care costs. The purpose of this study is to test the effectiveness of a patient centered self-management intervention to improve health outcomes in adults with type 2 DM. It is expected that patients receiving this intervention would have improved health outcomes as compared to patients who did not.
Read the detailed description
Background: In Pakistan, the rising burden of type 2 Diabetes Mellitus (DM) and its associated complications is considerably affecting the functional capacity of the individuals, their quality of life and demand for healthcare services with significant economic impact on health care system and the national economy. Given its enormous health and economic impact, preventing type 2 DM progression and reducing the risk of associated complications requires immediate attention. Evidence suggests that self-management can slow the progression of type 2 DM and minimize the risk of major complications thereby lowering health-care costs. Efective self-management on the other hand, demands patients' confidence and their full commitment to perform self care tasks necessitating a patient-centered approach.
Objective: To test the efficacy of a patient centered self-management intervention to improve glycemic control, self-efficacy and self-care behaviors in adults with type 2 DM.
Setting, Duration, Study Type: The study will be carried out as a randomized controlled trial (RCT) in four public tertiary care hospitals in Faisalabad, Pakistan.
Methods: A total 612 subjects will be recruited from out-patient departments (OPDs) of the study hospitals. Using random allocation 306 subjects will be assigned to the control group and 306 to the intervention group. Both the control group and the intervention group will receive usual care delivered at study hospitals. The intervention group will additionally receive a patient centered self-management Intervention for eight weeks duration.
Expected Outcome: If the study is able to show that the intervention group had improved glycemic control, self-efficacy and self-care behaviors than the control group. Then, employing hospital policies, this evidence-based care may be provided to all DM patients.
- Conditions
- Type 2 Diabetes
- Being tested
- PAtient CEntered Self-Management Intervention (PACE-SMI)
- Keywords
- Type 2 Diabetes, Self-management, Patient Centred Care, RCT
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAtient CEntered Self-Management Intervention (PACE-SMI)Behavioural
Week 1: General disease knowledge. Week 2: Role of self-care behaviors towards effective management of type 2 diabetes, motivational video and real story of a diabetic patient to serve as a role-model. Lastly, provision of diabetes self-care guidebook.
Week 3: Home visit to observe facilitators and barriers on initiating and maintaining behavioral change with social support as a key strategy.
Week 4: ECB session on Diet. Week 5: ECB session on Physical Activity. Week 6: ECB session on Foot Care. Week 7: ECB session on Medication Adherence. Week 8: Booster session comprising reflection, performance feedback and review of behavioral goals fostering continued performance accomplishment and addressing difficulties of maintaining behaviour change over time.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (CG) | No intervention | The subjects in the Control Group (CG) will receive usual care as being received in study hospitals. Usual care at study hospitals involve consultaion with the physician which encompasses history taking, blood glucose measurement, prescription and provision of general education regarding lifestyle modification verbally or in the form of pamphelets. |
| Intervention Group (IG) | Experimental | The subjects in the Intervention Group (IG) will receive usual care as well as a nurse-led PAtient CEntered Self-Management Intervention (PACE-SMI). PACE-SMI will be delivered for eight weeks duration comprising eight face to face individual and group educational, couselling and behavioral (ECB) training sessions in addition to telephonic reminders and a home visit by Principal Investigator (PI) and Research Assistants (RA). Outcome variables will be measured at three points in time (at baseline, at completion of intervention and lastly, after three months follow-up). Receives: Behavioral: PAtient CEntered Self-Management Intervention (PACE-SMI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycemic Control (HbA1c)
HbA1c will be measured by collecting venous plasma samples and sending them to the single central laboratory to assure consistency and uniformity in methodology. The samples will be drawn by Data Collectors/Outcome Assessors and laboratory measurements will be performed by a trained laboratory technician.
Measured: HbA1c will be measured at three points in time (1) at baseline, (2) at completion of 8 weeks intervention, and (3) at three months follow-up
Secondary outcomes (2)
Self Efficacy
Self Efficacy will be measured on Diabetes management self-efficacy scale (DMSES). DMSES is a self-administered scale used to assess subjects's perceived confidence in their ability to manage blood sugar, diet, physical activity and foot care. The scale comprises of 20 items. Each item's response is rated on 11 point scale ranging from 'cant do at all (0)' to 'certain can do it' (10) with total score 0 to 200.
Measured: Self Efficacy will be measured at three points in time (1) at baseline, (2) at completion of 8 weeks intervention, and (3) at three months follow-up
Self Care Behaviors
Self Care Behaviors will be measured on Summary of diabetes self-care activities (SDSCA). SDSCA is a self-reported scale to measure self-care activities across diverse components of diabetes self-management. SDSCA comprises of 25 items with each item measuring the frequency of self-care activities by asking how often several self-care activities were carried out over past seven days period. Each item's response is rated on 7 point scale ranging from '0' to '7' with total score ranging from 0 to 175. A higher score would be the frequency of performing self-care activities.
Measured: Self care behaviors will be measured at three points in time (1) at baseline, (2) at completion of 8 weeks intervention, and (3) at three months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start21 Apr 2022
- Primary completion7 Feb 2023
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In parallel arm design, subjects are randomized to one or more study arms and each study arm will be allocated a different intervention. After randomization each subject stays in their assigned treatment arm for the duration of the study. Subjects receive the same treatment throughout the trial. The results are then compared.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 612 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shifa Tameer-e-Millat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kainat Asmat, Shifa Tameer-e-Millat University
- Investigators
- Khairunnisa Dhamani, PhD, Study director, Shifa Tameer e Millat University, Islamabad, PakistanErika Froelicher, PhD, Study director, Shifa Tameer-e-Millat UniversityRaisa Gul, PhD, Study director, Shifa Tameer-e-Millat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491252
- Sponsor's protocol ID
- 335-21
- Status last verified
- Apr 2023
- First submitted
- 4 Aug 2022
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asmat K, Dhamani K, Froelicher ES, Gul R. A Patient-Centered Self-Management Intervention to Improve Glycemic Control, Self-Efficacy and Self-Care Behaviors in Adults with Type 2 Diabetes Mellitus: A SPIRIT Compliant Study Protocol for Randomized Controlled Trial. Diabetes Metab Syndr Obes. 2023 Jan 26;16:225-236. doi: 10.2147/DMSO.S385715. eCollection 2023.
PubMed 36760576
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient-Centered Self-Management Intervention to Improve Glycemic Control, Self-Efficacy and Self-Care Behaviors in Adults With Type 2 Diabetes Mellitus: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05491252
- Acronym / sponsor ID
- 335-21
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Self-management, Patient Centred Care, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 612 participants (actual)
- Lead sponsor
- Shifa Tameer-e-Millat UniversityUniversity, hospital or other
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 7 Feb 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 8 Aug 2022 (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.
Type 2 Diabetes Mellitus (DM) is a serious health problem for Pakistan and around the world due to its increasing prevalence and the risk of adverse health outcomes including kidney failure, heart attack, stroke, leg amputation and blindness. These problems reduce the quality of life of individuals with type 2 DM and increase their financial burden, thereby affecting the national economy. Given its huge health and economic impact, preventing type 2 DM progression and reducing the risk of associated complications requires immediate attention. Evidence suggests that self-management can slow the progression of type 2 DM, minimizes the risk of major complications and hence, lowers health-care costs. The purpose of this study is to test the effectiveness of a patient centered self-management intervention to improve health outcomes in adults with type 2 DM. It is expected that patients receiving this intervention would have improved health outcomes as compared to patients who did not.
Detailed description
Background: In Pakistan, the rising burden of type 2 Diabetes Mellitus (DM) and its associated complications is considerably affecting the functional capacity of the individuals, their quality of life and demand for healthcare services with significant economic impact on health care system and the national economy. Given its enormous health and economic impact, preventing type 2 DM progression and reducing the risk of associated complications requires immediate attention. Evidence suggests that self-management can slow the progression of type 2 DM and minimize the risk of major complications thereby lowering health-care costs. Efective self-management on the other hand, demands patients' confidence and their full commitment to perform self care tasks necessitating a patient-centered approach.
Objective: To test the efficacy of a patient centered self-management intervention to improve glycemic control, self-efficacy and self-care behaviors in adults with type 2 DM.
Setting, Duration, Study Type: The study will be carried out as a randomized controlled trial (RCT) in four public tertiary care hospitals in Faisalabad, Pakistan.
Methods: A total 612 subjects will be recruited from out-patient departments (OPDs) of the study hospitals. Using random allocation 306 subjects will be assigned to the control group and 306 to the intervention group. Both the control group and the intervention group will receive usual care delivered at study hospitals. The intervention group will additionally receive a patient centered self-management Intervention for eight weeks duration.
Expected Outcome: If the study is able to show that the intervention group had improved glycemic control, self-efficacy and self-care behaviors than the control group. Then, employing hospital policies, this evidence-based care may be provided to all DM patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- In parallel arm design, subjects are randomized to one or more study arms and each study arm will be allocated a different intervention. After randomization each subject stays in their assigned treatment arm for the duration of the study. Subjects receive the same treatment throughout the trial. The results are then compared.
| Arm | Type | Receives |
|---|---|---|
| Control Group (CG) | No intervention | –The subjects in the Control Group (CG) will receive usual care as being received in study hospitals. Usual care at study hospitals involve consultaion with the physician which encompasses history taking, blood glucose measurement, prescription and provision of general education regarding lifestyle modification verbally or in the form of pamphelets. |
| Intervention Group (IG) | Experimental | Behavioral: PAtient CEntered Self-Management Intervention (PACE-SMI)The subjects in the Intervention Group (IG) will receive usual care as well as a nurse-led PAtient CEntered Self-Management Intervention (PACE-SMI). PACE-SMI will be delivered for eight weeks duration comprising eight face to face individual and group educational, couselling and behavioral (ECB) training sessions in addition to telephonic reminders and a home visit by Principal Investigator (PI) and Research Assistants (RA). Outcome variables will be measured at three points in time (at baseline, at completion of intervention and lastly, after three months follow-up). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (aged 18 years or above)
- Diagnosed with type 2 Diabetes Mellitus for at least 06 months duration.
- Willing to participate in the study by signing of the consent form.
Key exclusion criteria (5 listed)
- Type 2 DM Patient with HbA1c < 7
- Uncontrolled psychological comorbidity (psychosis, schizophrenia, dementia or severe learning difficulties).
- Severe comorbidity that may limit participation (medical conditions such as cancer, stroke with disabilities, or need for regular dialysis etc. that preclude complete participation in this study).
- Life expectancy of less than six months as determined by patient's primary physician.
- Living outside of Faisalabad City.
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 |
|---|---|---|
| PAtient CEntered Self-Management Intervention (PACE-SMI)Week 1: General disease knowledge. Week 2: Role of self-care behaviors towards effective management of type 2 diabetes, motivational video and real story of a diabetic patient to serve as a role-model. Lastly, provision of diabetes self-care guidebook. Week 3: Home visit to observe facilitators and barriers on initiating and maintaining behavioral change with social support as a key strategy. Week 4: ECB session on Diet. Week 5: ECB session on Physical Activity. Week 6: ECB session on Foot Care. Week 7: ECB session on Medication Adherence. Week 8: Booster session comprising reflection, performance feedback and review of behavioral goals fostering continued performance accomplishment and addressing difficulties of maintaining behaviour change over time. | Behavioural | Intervention Group (IG) |
Primary outcome
Change in Glycemic Control (HbA1c)
Time frame: HbA1c will be measured at three points in time (1) at baseline, (2) at completion of 8 weeks intervention, and (3) at three months follow-up
HbA1c will be measured by collecting venous plasma samples and sending them to the single central laboratory to assure consistency and uniformity in methodology. The samples will be drawn by Data Collectors/Outcome Assessors and laboratory measurements will be performed by a trained laboratory technician.
2 secondary outcomes
Self Efficacy
Time frame: Self Efficacy will be measured at three points in time (1) at baseline, (2) at completion of 8 weeks intervention, and (3) at three months follow-up
Self Care Behaviors
Time frame: Self care behaviors will be measured at three points in time (1) at baseline, (2) at completion of 8 weeks intervention, and (3) at three months follow-up
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 11 Apr 2023.
- Derived from this study: PubMed 36760576Asmat K, Dhamani K, Froelicher ES, Gul R. A Patient-Centered Self-Management Intervention to Improve Glycemic Control, Self-Efficacy and Self-Care Behaviors in Adults with Type 2 Diabetes Mellitus: A SPIRIT Compliant Study Protocol for Randomized Controlled Trial. Diabetes Metab Syndr Obes. 2023 Jan 26;16:225-236. doi: 10.2147/DMSO.S385715. eCollection 2023.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
Recruiting
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
Type 2 Diabetes
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
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.
Khairunnisa Dhamani, PhD study director
Shifa Tameer e Millat University, Islamabad, Pakistan
Erika Froelicher, PhD study director
Shifa Tameer-e-Millat University
Raisa Gul, PhD study director
Shifa Tameer-e-Millat University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAtient CEntered Self-Management Intervention (PACE-SMI) in people with Type 2 Diabetes, run by Shifa Tameer-e-Millat University at 4 sites in Pakistan.
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 3 inclusion and 5 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 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Pakistan. 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?
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?
Change in Glycemic Control (HbA1c) (time frame: HbA1c will be measured at three points in time (1) at baseline, (2) at completion of 8 weeks intervention, and (3) at three months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05491252, which also lists 1 linked publication.
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 11 Apr 2023.