Diabetes DistressCEDDNCT03617146
Coaching and Education for Diabetes Distress
A study testing Health coaching and Diabetes Distress-specific Education in people with Diabetes Distress, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Diabetes distress (DD) is a negative emotional reaction to a diagnosis of diabetes and concerns about the burden of managing diabetes, the risk of complications, and inadequate support system. DD is common among people with diabetes and is strongly associated with poor diabetes self-care and poor diabetes control. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Distress
- What is being tested?
- Health coaching and Diabetes Distress-specific Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2018to 17 Sep 2020
- 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
- Has had a diagnosis of type 2 diabetes for at least 6 months
- Aged 18 to 75 years
- Most recent HbA1c taken within 30 days was ≥ 8.0
- At least moderate diabetes distress (a mean score ≥ 2.0 on the 17-item Diabetes Distress Scale).
Who cannot join
- Moderately-severe to severe depression: Patient Health Questionnaire (PHQ9) score ≥15
- Other severe mental health disorder (e.g. Alzheimer's, schizophrenia)
- Current pregnancy
- Severe diabetes complications or functional deficits (e.g. kidney failure requiring dialysis, amputation, blindness).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coaching and Education for Diabetes Distress: a Randomized Controlled Trial (CEDD Trial)
Diabetes distress (DD) is a negative emotional reaction to a diagnosis of diabetes and concerns about the burden of managing diabetes, the risk of complications, and inadequate support system. DD is common among people with diabetes and is strongly associated with poor diabetes self-care and poor diabetes control. Reducing DD should thus be an important component of diabetes management. In line with the growing evidence, the American Diabetes Association now recommends that providers "routinely monitor people with diabetes for diabetes distress, particularly when treatment targets are not met". Despite increased recognition of the need to manage DD, interventions that are both feasible and effective for reducing DD in routine care settings are not yet known. A pilot study showed that health coaching (HC) has some efficacy in addressing DD but no adequately powered study has implemented a pragmatic research design capable of assessing the real-world effectiveness of HC in reducing DD.
This study seeks to assess whether HC effectively reduces DD among primary care patients with diabetes, and whether HC is more effective than an educational program targeting DD. The investigators hypothesize that over a 6-month period, patients with poorly controlled diabetes and DD who enroll in and complete at least five HC sessions will achieve higher and clinically significant reductions in DD and HbA1c, and greater compliance with diabetes self-care recommendations than those who receive only an educational program targeting DD as part of usual diabetes care.
The two-arm randomized controlled trial for patients with poorly-controlled diabetes is taking place at an academic family medicine practice in Houston, Texas. Both arms will receive usual care, which includes education about DD. In addition, the intervention arm will receive eight HC sessions over a five-month period. The primary outcome measure is reduction in DD over a six month period. Additional outcome measures include changes in glycemic control (HbA1C) and self-care practices (medication adherence, dietary, and physical activity behaviors). The study will also measure satisfaction and willingness-to-pay for HC to determine the extent to which HC, if effective for reducing DD, can be operationalized in similar healthcare settings.
- Conditions
- Diabetes Distress
- Being tested
- Health coaching, Diabetes Distress-specific Education
- Keywords
- Diabetes Distress, Diabetes Mellitus, Diabetes Control, Health Coaching, Diabetes Self-management
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health coachingBehavioural
Also called Telecoaching
The intervention will seek to help participants express their diabetes emotional needs and to work with them to figure out what can be done to meet those needs. Depending on the unique needs of each participant, the coaching approach for this study will include: improving motivation and self-efficacy for diabetes management using motivational interviewing and appreciative inquiry; building trust and rapport through mindful listening, open-ended inquiry, and perceptive reflections; and expressing empathy through nonviolent communication. Each participant will receive eight individual coaching sessions over a five month period. All coaching sessions will be delivered over the phone (i.e. telecoaching). The coaching intervention will be done by a certified health and wellness coach.
Diabetes Distress-specific EducationOther
A diabetes distress-specific education that explains what diabetes distress is, why it matters, and its four domains. In addition, the participant is given feedback on his or her distress score and advised on ways to deal with the areas of greatest distress. Participant is linked with resources to overcome any expressed needs. The education is provided by a trained medical assistant.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants in the intervention arm will receive the following interventions:
Month 1: Diabetes Distress-specific Education.
Months 1 to 3: Six 30 to 45-minute telephone-based health coaching sessions targeting diabetes distress reduction and self-care improvement.
Month 3: Follow up distress-specific education.
Months 4 and 5: Two 30 to 45 minute telephone-based health coaching sessions targeting diabetes distress reduction and self-care improvement. Receives: Behavioral: Health coaching; Other: Diabetes Distress-specific Education |
| Control Arm | Active comparator | Participants in the control arm will receive the following interventions:
Month 1: Diabetes Distress-specific Education (same as for the intervention arm).
Month 3: Follow up distress-specific education (same as for the intervention arm). Receives: Other: Diabetes Distress-specific Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes distress score
Change in diabetes distress score as measured by the diabetes distress scale (DDS). DDS scores range from 1 to 6, with scores that are less than 2.0 being indicative of little or no distress. Hence scores of 2.0 and above are significant and higher values are indicative of worse outcome.
Measured: 3 months and 6 months from baseline
Secondary outcomes (2)
HbA1c
Change in glycemic control as measured by HbA1c
Measured: 3 months and 6 months from baseline
Self-care behaviors (medication adherence, dietary practices, and physical activity behaviors)
Change in medication adherence, dietary practices, and physical activity behaviors, as measured by the respective medication, diet, and exercise subscales of the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire.
Measured: 3 months and 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start15 Jun 2018
- Primary completion25 Feb 2020
- Study completion17 Sep 2020
Why it stopped: Recruitment challenges.
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 Diabetes DistressStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles C Chima, Baylor College of Medicine
- Investigators
- Charles Chima, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617146
- Sponsor's protocol ID
- 52960-I
- Acronym
- CEDD
- Status last verified
- Jan 2021
- First submitted
- 27 Jul 2018
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chima CC, Salemi JL, Sidani MA, Zoorob RJ. Coaching and Education for Diabetes Distress (CEDD): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Apr 2;8(4):e12166. doi: 10.2196/12166.
PubMed 30938687
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coaching and Education for Diabetes Distress: a Randomized Controlled Trial (CEDD Trial)
- ClinicalTrials.gov ID
- NCT03617146
- Acronym / sponsor ID
- CEDD / 52960-I
- Conditions
- Diabetes Distress
- Keywords
- Diabetes Distress, Diabetes Mellitus, Diabetes Control, Health Coaching, Diabetes Self-management
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment challenges.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 17 Sep 2020 (actual)
- First posted
- 6 Aug 2018 (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.
Diabetes distress (DD) is a negative emotional reaction to a diagnosis of diabetes and concerns about the burden of managing diabetes, the risk of complications, and inadequate support system. DD is common among people with diabetes and is strongly associated with poor diabetes self-care and poor diabetes control. Reducing DD should thus be an important component of diabetes management. In line with the growing evidence, the American Diabetes Association now recommends that providers "routinely monitor people with diabetes for diabetes distress, particularly when treatment targets are not met". Despite increased recognition of the need to manage DD, interventions that are both feasible and effective for reducing DD in routine care settings are not yet known. A pilot study showed that health coaching (HC) has some efficacy in addressing DD but no adequately powered study has implemented a pragmatic research design capable of assessing the real-world effectiveness of HC in reducing DD.
This study seeks to assess whether HC effectively reduces DD among primary care patients with diabetes, and whether HC is more effective than an educational program targeting DD. The investigators hypothesize that over a 6-month period, patients with poorly controlled diabetes and DD who enroll in and complete at least five HC sessions will achieve higher and clinically significant reductions in DD and HbA1c, and greater compliance with diabetes self-care recommendations than those who receive only an educational program targeting DD as part of usual diabetes care.
The two-arm randomized controlled trial for patients with poorly-controlled diabetes is taking place at an academic family medicine practice in Houston, Texas. Both arms will receive usual care, which includes education about DD. In addition, the intervention arm will receive eight HC sessions over a five-month period. The primary outcome measure is reduction in DD over a six month period. Additional outcome measures include changes in glycemic control (HbA1C) and self-care practices (medication adherence, dietary, and physical activity behaviors). The study will also measure satisfaction and willingness-to-pay for HC to determine the extent to which HC, if effective for reducing DD, can be operationalized in similar healthcare settings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Health coaching, Other: Diabetes Distress-specific EducationParticipants in the intervention arm will receive the following interventions: Month 1: Diabetes Distress-specific Education. Months 1 to 3: Six 30 to 45-minute telephone-based health coaching sessions targeting diabetes distress reduction and self-care improvement. Month 3: Follow up distress-specific education. Months 4 and 5: Two 30 to 45 minute telephone-based health coaching sessions targeting diabetes distress reduction and self-care improvement. |
| Control Arm | Active comparator | Other: Diabetes Distress-specific EducationParticipants in the control arm will receive the following interventions: Month 1: Diabetes Distress-specific Education (same as for the intervention arm). Month 3: Follow up distress-specific education (same as for the intervention arm). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has had a diagnosis of type 2 diabetes for at least 6 months
- Aged 18 to 75 years
- Most recent HbA1c taken within 30 days was ≥ 8.0
- At least moderate diabetes distress (a mean score ≥ 2.0 on the 17-item Diabetes Distress Scale).
Key exclusion criteria (4 listed)
- Moderately-severe to severe depression: Patient Health Questionnaire (PHQ9) score ≥15
- Other severe mental health disorder (e.g. Alzheimer's, schizophrenia)
- Current pregnancy
- Severe diabetes complications or functional deficits (e.g. kidney failure requiring dialysis, amputation, blindness).
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 |
|---|---|---|
| Health coachingAlso: TelecoachingThe intervention will seek to help participants express their diabetes emotional needs and to work with them to figure out what can be done to meet those needs. Depending on the unique needs of each participant, the coaching approach for this study will include: improving motivation and self-efficacy for diabetes management using motivational interviewing and appreciative inquiry; building trust and rapport through mindful listening, open-ended inquiry, and perceptive reflections; and expressing empathy through nonviolent communication. Each participant will receive eight individual coaching sessions over a five month period. All coaching sessions will be delivered over the phone (i.e. telecoaching). The coaching intervention will be done by a certified health and wellness coach. | Behavioural | Intervention Arm |
| Diabetes Distress-specific EducationA diabetes distress-specific education that explains what diabetes distress is, why it matters, and its four domains. In addition, the participant is given feedback on his or her distress score and advised on ways to deal with the areas of greatest distress. Participant is linked with resources to overcome any expressed needs. The education is provided by a trained medical assistant. | Other | Control Arm, Intervention Arm |
Primary outcome
Diabetes distress score
Time frame: 3 months and 6 months from baseline
Change in diabetes distress score as measured by the diabetes distress scale (DDS). DDS scores range from 1 to 6, with scores that are less than 2.0 being indicative of little or no distress. Hence scores of 2.0 and above are significant and higher values are indicative of worse outcome.
2 secondary outcomes
HbA1c
Time frame: 3 months and 6 months from baseline
Self-care behaviors (medication adherence, dietary practices, and physical activity behaviors)
Time frame: 3 months and 6 months from baseline
Results and safety
The study was stopped early (reason given: Recruitment challenges.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Derived from this study: PubMed 30938687Chima CC, Salemi JL, Sidani MA, Zoorob RJ. Coaching and Education for Diabetes Distress (CEDD): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Apr 2;8(4):e12166. doi: 10.2196/12166.
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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.
Charles Chima principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health coaching and Diabetes Distress-specific Education in people with Diabetes Distress, run by Baylor College of Medicine 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 4 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: stopped early, as of the sponsor's last update on 22 Jan 2021. 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 was stopped early (reason given: Recruitment challenges.). Results are not available in the source record.
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?
Diabetes distress score (time frame: 3 months and 6 months from baseline). 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 NCT03617146, 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 22 Jan 2021.