DiabetesSTOP-DKDNCT01829256
Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD)
A study testing Pharmacist telehealth intervention in people with Diabetes and Hypertension, run by Duke University at 1 site in United States.
Trial summary
Diabetic kidney disease (DKD) is associated with high rates of cardiovascular events and death. In addition, DKD is the major cause of end-stage renal disease (ESRD) in the United States. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes, Hypertension, Diabetic Kidney Disease
- What is being tested?
- Pharmacist telehealth intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 7 Nov 2018
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 and less than75 years
- regular use of the Duke University Health System (≥2 primary care visits in 3 prior yrs)
- diagnosis of type 2 diabetes
- have at least 2 serum creatinine values available in the 3 prior years, separated by at least 3 months;
- preserved kidney function (eGFR between 45-90 ml/min/1.73m2 on most recent creatinine)
- evidence of diabetic nephropathy
- uncontrolled HTN (1y mean clinic SBP≥140 and/or DBP≥90).
Who cannot join
- no access to telephone
- not proficient in English
- nursing home/long-term care facility resident or receiving home health care
- impaired hearing/ speech/ vision
- participating in another trial (pharmaceutical or behavioral)
- planning to leave the area in the next 3 years
Show all 16Show fewer
- pancreatic insufficiency or diabetes secondary to pancreatitis
- alcohol abuse (>14 alcoholic beverages/ wk)
- diagnosis of non-diabetic kidney disease
- active malignancy (other than non-melanomatous skin cancer)
- life-threatening disease with death probable within 4 years
- Secondary hypertension (renovascular disease, Cushing's syndrome, primary aldosteronism, pheochromocytoma, hypo-/hyperthyroidism, hyperparathyroidism, coarctation of the aorta)
- Pregnancy, Breastfeeding
- Long-term or chronic dialysis
- Dementia
- Renal Transplant
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System Clinics
Durham, North Carolina, 27705
About this study
Official title: Simultaneous Risk Factor Control Using Telehealth to SlOw Progression of Diabetic Kidney Disease (STOP-DKD)
Diabetic kidney disease (DKD) is associated with high rates of cardiovascular events and death. In addition, DKD is the major cause of end-stage renal disease (ESRD) in the United States. The purpose of this study is to prevent progression of kidney disease among patients with DKD and uncontrolled hypertension (HTN) using a tailored, telehealth intervention that simultaneously address medication management and modifies multiple risk factors through a combination of patient self-monitoring, behavioral therapies and education to optimize adherence and self-efficacy. Additional goals are to improve control of cardiovascular disease risk factors and reduce cardiovascular events and death.
We hypothesize that patients with DKD and uncontrolled HTN who receive this intervention will have less progression, or a smaller decrease in kidney function, after 3 years when compared to the education control group.
Read the detailed description
A randomized, controlled trial to slow DKD progression:
- Using an innovative telehealth approach that is potentially scalable with demonstrable efficacy in reducing antecedents of kidney disease, including poor blood pressure, glucose, and lipid control
- Enrolling demographically diverse patients from local primary care clinics to allow applicability of our results to the general US population within existing delivery systems; and
- Targeting patients with moderate DKD (estimated glomerular filtration rate between 45-90 ml/min/1.73m2 with evidence of diabetic nephropathy) and uncontrolled HTN (blood pressure ≥140/90 mm Hg), accounting for about 20% of all patients with diabetes who disproportionately suffer from end-stage renal disease (ESRD), cardiovascular events, and death.
- Conditions
- Diabetes, Hypertension, Diabetic Kidney Disease
- Being tested
- Pharmacist telehealth intervention
- Medical subject headings
- Diabetes Mellitus, Hypertension, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist telehealth interventionBehavioural
A tailored intervention with medication management and behavioral components. The behavioral modules may include, diet, exercise, weight, tobacco use, medication management, side effects, diabetes education, DKD/ HTN/ CVD risk and knowledge.Based on the patient's responses to a series of questions, there will be a provision of tailored feedback to reinforce evidence-based behavior for disease and lifestyle management.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist Telehealth Intervention | Experimental | Will receive a tailored multi-factorial clinical pharmacist-administered telehealth intervention, which includes medication management and behavioral-educational components. The intervention will occur monthly over 3 years. Receives: Behavioral: Pharmacist telehealth intervention |
| Education Control | No intervention | Will receive educational material about management of kidney disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in kidney function as measured by estimated glomerular filtration rate based on cystatin C(eGFRcys)
Measured: Measured at Baseline and again at 36 months
Secondary outcomes (1)
Change in blood pressure, glucose/HbA1c and urine albumin
Measured: Measured at baseline and again at 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startMay 2014
- Primary completion7 Nov 2018
- Study completion7 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hayden Bosworth, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829256
- Sponsor's protocol ID
- Pro00044811
- Acronym
- STOP-DKD
- Status last verified
- Feb 2019
- First submitted
- 9 Apr 2013
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Cashmore BA, Cooper TE, Evangelidis NM, Green SC, Lopez-Vargas P, Tunnicliffe DJ. Education programmes for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD007374. doi: 10.1002/14651858.CD007374.pub3.
PubMed 39171639Machen L, Davenport CA, Oakes M, Bosworth HB, Patel UD, Diamantidis C. Race, Income, and Medical Care Spending Patterns in High-Risk Primary Care Patients: Results From the STOP-DKD (Simultaneous Risk Factor Control Using Telehealth to Slow Progression of Diabetic Kidney Disease) Study. Kidney Med. 2021 Oct 26;4(1):100382. doi: 10.1016/j.xkme.2021.08.016. eCollection 2022 Jan.
PubMed 35072046Zullig LL, Oakes MM, McCant F, Bosworth HB. Lessons learned from two randomized controlled trials: CITIES and STOP-DKD. Contemp Clin Trials Commun. 2020 Jul 8;19:100612. doi: 10.1016/j.conctc.2020.100612. eCollection 2020 Sep.
PubMed 32685766Zullig LL, Jazowski SA, Davenport CA, Diamantidis CJ, Oakes MM, Patel S, Moaddeb J, Bosworth HB. Primary Care Providers' Acceptance of Pharmacists' Recommendations to Support Optimal Medication Management for Patients with Diabetic Kidney Disease. J Gen Intern Med. 2020 Jan;35(1):63-69. doi: 10.1007/s11606-019-05403-x. Epub 2019 Oct 28.
PubMed 31659655Diamantidis CJ, Bosworth HB, Oakes MM, Davenport CA, Pendergast JF, Patel S, Moaddeb J, Barnhart HX, Merrill PD, Baloch K, Crowley MJ, Patel UD. Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study: Protocol and baseline characteristics of a randomized controlled trial. Contemp Clin Trials. 2018 Jun;69:28-39. doi: 10.1016/j.cct.2018.04.003. Epub 2018 Apr 10.
PubMed 29649631
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Risk Factor Control Using Telehealth to SlOw Progression of Diabetic Kidney Disease (STOP-DKD)
- ClinicalTrials.gov ID
- NCT01829256
- Acronym / sponsor ID
- STOP-DKD / Pro00044811
- Conditions
- Diabetes, Hypertension, Diabetic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- 7 Nov 2018 (actual)
- Study completion
- 7 Nov 2018 (actual)
- First posted
- 11 Apr 2013 (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.
Diabetic kidney disease (DKD) is associated with high rates of cardiovascular events and death. In addition, DKD is the major cause of end-stage renal disease (ESRD) in the United States. The purpose of this study is to prevent progression of kidney disease among patients with DKD and uncontrolled hypertension (HTN) using a tailored, telehealth intervention that simultaneously address medication management and modifies multiple risk factors through a combination of patient self-monitoring, behavioral therapies and education to optimize adherence and self-efficacy. Additional goals are to improve control of cardiovascular disease risk factors and reduce cardiovascular events and death.
We hypothesize that patients with DKD and uncontrolled HTN who receive this intervention will have less progression, or a smaller decrease in kidney function, after 3 years when compared to the education control group.
Detailed description
A randomized, controlled trial to slow DKD progression:
- Using an innovative telehealth approach that is potentially scalable with demonstrable efficacy in reducing antecedents of kidney disease, including poor blood pressure, glucose, and lipid control
- Enrolling demographically diverse patients from local primary care clinics to allow applicability of our results to the general US population within existing delivery systems; and
- Targeting patients with moderate DKD (estimated glomerular filtration rate between 45-90 ml/min/1.73m2 with evidence of diabetic nephropathy) and uncontrolled HTN (blood pressure ≥140/90 mm Hg), accounting for about 20% of all patients with diabetes who disproportionately suffer from end-stage renal disease (ESRD), cardiovascular events, and death.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist Telehealth Intervention | Experimental | Behavioral: Pharmacist telehealth interventionWill receive a tailored multi-factorial clinical pharmacist-administered telehealth intervention, which includes medication management and behavioral-educational components. The intervention will occur monthly over 3 years. |
| Education Control | No intervention | –Will receive educational material about management of kidney disease |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age ≥18 and less than75 years
- regular use of the Duke University Health System (≥2 primary care visits in 3 prior yrs)
- diagnosis of type 2 diabetes
- have at least 2 serum creatinine values available in the 3 prior years, separated by at least 3 months;
- preserved kidney function (eGFR between 45-90 ml/min/1.73m2 on most recent creatinine)
Key exclusion criteria (16 listed)
- no access to telephone
- not proficient in English
- nursing home/long-term care facility resident or receiving home health care
- impaired hearing/ speech/ vision
- participating in another trial (pharmaceutical or behavioral)
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 |
|---|---|---|
| Pharmacist telehealth interventionA tailored intervention with medication management and behavioral components. The behavioral modules may include, diet, exercise, weight, tobacco use, medication management, side effects, diabetes education, DKD/ HTN/ CVD risk and knowledge.Based on the patient's responses to a series of questions, there will be a provision of tailored feedback to reinforce evidence-based behavior for disease and lifestyle management. | Behavioural | Pharmacist Telehealth Intervention |
Primary outcome
Change in kidney function as measured by estimated glomerular filtration rate based on cystatin C(eGFRcys)
Time frame: Measured at Baseline and again at 36 months
1 secondary outcome
Change in blood pressure, glucose/HbA1c and urine albumin
Time frame: Measured at baseline and again at 36 months
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 7 Feb 2019.
- Derived from this study: PubMed 39171639Cashmore BA, Cooper TE, Evangelidis NM, Green SC, Lopez-Vargas P, Tunnicliffe DJ. Education programmes for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD007374. doi: 10.1002/14651858.CD007374.pub3.
- Derived from this study: PubMed 35072046Machen L, Davenport CA, Oakes M, Bosworth HB, Patel UD, Diamantidis C. Race, Income, and Medical Care Spending Patterns in High-Risk Primary Care Patients: Results From the STOP-DKD (Simultaneous Risk Factor Control Using Telehealth to Slow Progression of Diabetic Kidney Disease) Study. Kidney Med. 2021 Oct 26;4(1):100382. doi: 10.1016/j.xkme.2021.08.016. eCollection 2022 Jan.
- Derived from this study: PubMed 32685766Zullig LL, Oakes MM, McCant F, Bosworth HB. Lessons learned from two randomized controlled trials: CITIES and STOP-DKD. Contemp Clin Trials Commun. 2020 Jul 8;19:100612. doi: 10.1016/j.conctc.2020.100612. eCollection 2020 Sep.
- Derived from this study: PubMed 31659655Zullig LL, Jazowski SA, Davenport CA, Diamantidis CJ, Oakes MM, Patel S, Moaddeb J, Bosworth HB. Primary Care Providers' Acceptance of Pharmacists' Recommendations to Support Optimal Medication Management for Patients with Diabetic Kidney Disease. J Gen Intern Med. 2020 Jan;35(1):63-69. doi: 10.1007/s11606-019-05403-x. Epub 2019 Oct 28.
- Derived from this study: PubMed 29649631Diamantidis CJ, Bosworth HB, Oakes MM, Davenport CA, Pendergast JF, Patel S, Moaddeb J, Barnhart HX, Merrill PD, Baloch K, Crowley MJ, Patel UD. Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study: Protocol and baseline characteristics of a randomized controlled trial. Contemp Clin Trials. 2018 Jun;69:28-39. doi: 10.1016/j.cct.2018.04.003. Epub 2018 Apr 10.
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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.
Hayden Bosworth, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist telehealth intervention in people with Diabetes and Hypertension, run by Duke University at 1 site in United States.
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 7 inclusion and 16 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 7 Feb 2019. 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 United States. 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 kidney function as measured by estimated glomerular filtration rate based on cystatin C(eGFRcys) (time frame: Measured at Baseline and again at 36 months). 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 NCT01829256, which also lists 5 linked publications.
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 7 Feb 2019.