Diabetes Mellitus, Type 2NCT02081573
Brief CBT Interventions Delivered by Nurse Care Managers to Improve Type 2 Diabetes Outcomes: Pilot Study
A study testing Brief CBT in people with Diabetes Mellitus, Type 2, run by University of Pittsburgh at 1 site in United States.
Trial summary
Primary aim: examine feasibility and acceptability of a brief cognitive therapy protocol for type II diabetes administered by nurse care managers or health coaches via phone. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Brief CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ten adults will be recruited through the UPMC health plan and are treated at a primary care center. To be considered for inclusion subjects must:
- have a diagnosis of T2DM;
- have a score of >3 on the Diabetes Distress Scale;
- be taking at least one oral antihyperglycemic agent (the patient may also be using injectable antihyperglycemic medications, including insulin);
- have an HbA1c level of greater than 8 at baseline;
- be receiving treatment for T2DM in the primary care setting;
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- be aged 30 - 65 years and
- be able to read at the 8th-grade level and to provide informed consent.
- Four nurse care managers will also be recruited from UPMC Health Care. To be considered they must be employed at UPMC Health Care and
- Have received the Brief CBT Training that was given in Phase I of this study;
- Be identified as a RN or a RN who is a diabetes nurse educator; and have Nurse Care Management responsibilities with patients who have Type 2 Diabetes.
- Nurses will be excluded from the study if:
- They did not successfully complete the training in Phase I or
- Are not Nurse Care Managers at UPMC Health Care. -
Who cannot join
- The following are exclusion criteria:
- major psychiatric disorder and suicidal risk;
- dementia or disorders with substantial cognitive impairment. -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh School of Nursing
Pittsburgh, Pennsylvania, 15261
About this study
Primary aim: examine feasibility and acceptability of a brief cognitive therapy protocol for type II diabetes administered by nurse care managers or health coaches via phone.
Read the detailed description
A significant problem in primary care healthcare delivery is the lack of interventions to improve medication and overall regimen adherence in persons with Type 2 diabetes (T2DM). Diabetes distress, a negative response to the diagnosis of T2DM, danger of complications, and self-management burdens is present in up to 70% of persons with T2DM. Distress is a significant factor in medication nonadherence and poor glycemic control. Treatment adherence is vital to maintain glucose control and reduce complications.
The literature has identified dysfunctional thinking patterns such as beliefs (e.g., I can't handle taking these medications), assumptions (e.g., I know I will have side effects to these medications) and interpretations (e.g., I'm too overwhelmed to do all of this stuff) as critical variables that impact both distress and T2DM treatment adherence. Current treatment strategies within primary care do not address the dysfunctional thinking patterns that affect the patient's distress level, T2DM medication adherence, and complex daily self-care activities.
Cognitive behavior therapy (CBT), a well-established evidenced-based treatment, helps patients to identify, and restructure dysfunctional thinking patterns. We propose to test a brief CBT approach delivered by nurse care managers and supported by a comprehensive mobile phone CBT skills practice application (app) within primary care. The promising results of our preliminary studies using a mobile phone app to stimulate real-time CBT skills practice prompt us to propose a pilot of its use with patients with T2DM with the following aims:
Primary aim: examine feasibility and acceptability of the assessment protocol, and the recruitment, and retention of study participants.
Secondary aim: 1) collect preliminary data on the effect of the intervention on clinical outcomes, e.g., self-reported adherence to medication and self-management adherence, e.g., diet, exercise; levels of diabetes distress, diabetes medication beliefs, and distal T2DM outcomes (HbA1c level and body mass index).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Brief CBT
- Keywords
- Brief CBT, smartphone app, mHealth, diabetes distress, adherence, cognitive behavioral therapy
- 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.
Brief CBTBehavioural
Also called CBT MobileWork
During the course of the twice/month diabetes management phone sessions the nurse care manager will work collaboratively with the patient to identify a dysfunctional belief that may be affecting adherence and could be improved by a brief CBT intervention (5-7 minutes). The care manager will utilize the CBT phone app to identify a CBT intervention that will be most appropriate for the situation. Each intervention is described step by step in the app. The nurse will go through the intervention and when completed will assure the patient's understanding.CBT interventions are geared towards helping the patient identify and restructure thinking that is impairing successful self-management of a chronic disease
| Study group | Role | What they receive |
|---|---|---|
| Brief CBT | Experimental | During the course of the twice/month diabetes management phone sessions the nurse care manager will work collaboratively with the patient to identify a dysfunctional belief that may be affecting adherence and could be improved by a brief CBT intervention (5-7 minutes). The care manager will utilize the CBT phone app to identify a CBT intervention that will be most appropriate for the situation. Each intervention is described step by step in the app. The nurse will go through the intervention and when completed will assure the patient's understanding.CBT interventions are geared towards helping the patient identify and restructure thinking that is impairing successful self-management of a chronic disease Receives: Behavioral: Brief CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability Questionnaire.
The acceptability questionnaire measures feasibility and acceptability of the Brief CBT protocol. Adapted from Lewis JR.: IBM Computer Usability Satisfaction Questionnaires: Psychometric Evaluation and Instructions for Use. International Journal of Human-Computer Interaction 1995; 7 (1):67-78. Scale is scored as a mean and ranges from 1-7. In this adaptation, lower scores are better satisfaction.
Measured: 12 weeks
Secondary outcomes (5)
Morisky Questionnaire
Brief scale of adherence to medications. Morisky 5 items was used. Mean score presented. Scale range is from 5-13. Lower score is better adherence. Mean change from baseline to 12 weeks is examined.
Measured: 12 weeks
Diabetes Distress Scale
Levels of diabetes distress per standardized questionnaire will be measured before intervention and after intervention. Change of mean score is reported. Change in score from baseline to post followup. Lower score means less distress. Scale range is from 1-6. Adapted from Fisher, L., Glasgow, R.E., Mullan, J.T., Skaff, M.M., Polonsky, W.H. (2008) Development of a Brief Diabetes Screening Instrument. Annals of Family Medicine; 6:246-252.
Measured: 12 weeks
Medication Beliefs Scale
Change in medication beliefs from before and after intervention. Adapted from Horne, R., Weinman, J., Hankins, M. (1999). The Beliefs About Medicines Questionnaire: The Development and Evaluation of a New Method for Assessing the Cognitive Representation of Medications. Psychology and Health 14: 1-24.
Measured: 12 weeks
HbA1c Level
Change in HbA1c from before to after treatment
Measured: 12 weeks
Body Mass Index
Change in Body Mass Index from before to after treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startJan 2013
- Primary completionJul 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judith A. Callan PhD. RN, University of Pittsburgh
- Investigators
- Judith A. Callan, PhD, RN, Principal investigator, University of Pittsburgh School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081573
- Sponsor's protocol ID
- PRO13050427
- Other IDs
- School of Nursing eHub pilot
- Status last verified
- Mar 2018
- First submitted
- 3 Mar 2014
- Last updated
- 13 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: This is a small sample feasibility study.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief CBT Interventions Delivered by Nurse Care Managers to Improve Type 2 Diabetes Outcomes: Pilot Study
- ClinicalTrials.gov ID
- NCT02081573
- Acronym / sponsor ID
- PRO13050427
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Brief CBT, smartphone app, mHealth, diabetes distress, adherence, cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Posted 13 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary aim: examine feasibility and acceptability of a brief cognitive therapy protocol for type II diabetes administered by nurse care managers or health coaches via phone.
Detailed description
A significant problem in primary care healthcare delivery is the lack of interventions to improve medication and overall regimen adherence in persons with Type 2 diabetes (T2DM). Diabetes distress, a negative response to the diagnosis of T2DM, danger of complications, and self-management burdens is present in up to 70% of persons with T2DM. Distress is a significant factor in medication nonadherence and poor glycemic control. Treatment adherence is vital to maintain glucose control and reduce complications.
The literature has identified dysfunctional thinking patterns such as beliefs (e.g., I can't handle taking these medications), assumptions (e.g., I know I will have side effects to these medications) and interpretations (e.g., I'm too overwhelmed to do all of this stuff) as critical variables that impact both distress and T2DM treatment adherence. Current treatment strategies within primary care do not address the dysfunctional thinking patterns that affect the patient's distress level, T2DM medication adherence, and complex daily self-care activities.
Cognitive behavior therapy (CBT), a well-established evidenced-based treatment, helps patients to identify, and restructure dysfunctional thinking patterns. We propose to test a brief CBT approach delivered by nurse care managers and supported by a comprehensive mobile phone CBT skills practice application (app) within primary care. The promising results of our preliminary studies using a mobile phone app to stimulate real-time CBT skills practice prompt us to propose a pilot of its use with patients with T2DM with the following aims:
Primary aim: examine feasibility and acceptability of the assessment protocol, and the recruitment, and retention of study participants.
Secondary aim: 1) collect preliminary data on the effect of the intervention on clinical outcomes, e.g., self-reported adherence to medication and self-management adherence, e.g., diet, exercise; levels of diabetes distress, diabetes medication beliefs, and distal T2DM outcomes (HbA1c level and body mass index).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brief CBT | Experimental | Behavioral: Brief CBTDuring the course of the twice/month diabetes management phone sessions the nurse care manager will work collaboratively with the patient to identify a dysfunctional belief that may be affecting adherence and could be improved by a brief CBT intervention (5-7 minutes). The care manager will utilize the CBT phone app to identify a CBT intervention that will be most appropriate for the situation. Each intervention is described step by step in the app. The nurse will go through the intervention and when completed will assure the patient's understanding.CBT interventions are geared towards helping the patient identify and restructure thinking that is impairing successful self-management of a chronic disease |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Ten adults will be recruited through the UPMC health plan and are treated at a primary care center. To be considered for inclusion subjects must:
- have a diagnosis of T2DM;
- have a score of >3 on the Diabetes Distress Scale;
- be taking at least one oral antihyperglycemic agent (the patient may also be using injectable antihyperglycemic medications, including insulin);
- have an HbA1c level of greater than 8 at baseline;
Key exclusion criteria (3 listed)
- major psychiatric disorder and suicidal risk;
- dementia or disorders with substantial cognitive impairment. -
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 |
|---|---|---|
| Brief CBTAlso: CBT MobileWorkDuring the course of the twice/month diabetes management phone sessions the nurse care manager will work collaboratively with the patient to identify a dysfunctional belief that may be affecting adherence and could be improved by a brief CBT intervention (5-7 minutes). The care manager will utilize the CBT phone app to identify a CBT intervention that will be most appropriate for the situation. Each intervention is described step by step in the app. The nurse will go through the intervention and when completed will assure the patient's understanding.CBT interventions are geared towards helping the patient identify and restructure thinking that is impairing successful self-management of a chronic disease | Behavioural | Brief CBT |
Primary outcome
Acceptability Questionnaire.
Time frame: 12 weeks
The acceptability questionnaire measures feasibility and acceptability of the Brief CBT protocol. Adapted from Lewis JR.: IBM Computer Usability Satisfaction Questionnaires: Psychometric Evaluation and Instructions for Use. International Journal of Human-Computer Interaction 1995; 7 (1):67-78. Scale is scored as a mean and ranges from 1-7. In this adaptation, lower scores are better satisfaction.
5 secondary outcomes
Morisky Questionnaire
Time frame: 12 weeks
Diabetes Distress Scale
Time frame: 12 weeks
Medication Beliefs Scale
Time frame: 12 weeks
HbA1c Level
Time frame: 12 weeks
Body Mass Index
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. This is a small sample feasibility study.
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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.
Judith A. Callan, PhD, RN principal investigator
University of Pittsburgh School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief CBT in people with Diabetes Mellitus, Type 2, run by University of Pittsburgh 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 14 inclusion and 3 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 13 Mar 2018. 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?
Yes. Results are posted in the registry (first posted 13 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Acceptability Questionnaire. (time frame: 12 weeks). 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 13 Mar 2018.