Diabetes MellitusNCT03406923
Self-efficacy, Beliefs and Adherence- Pilot and Feasibility Trial of a Pharmacist-led Intervention
A study testing Health literacy-psychosocial support in people with Diabetes Mellitus, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study uses an intervention mixed methods design. The overall purpose is to improve medication adherence and assess the clinical impact on diabetes outcomes among patients with uncontrolled diabetes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Health literacy-psychosocial support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2018to 31 Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking men and women 18-80 years old with diabetes
- Taking oral diabetes medications and/or insulin
- One hemoglobin A1C measure of 8% or greater in the last 18 months
- A score less than 25 on the Medication Adherence Rating Scale (MARS-5)
Who cannot join
- Unable to provide informed consent
- Younger than 18 years old or older than 80 years old
- Unable to understand English
- Do not take oral diabetes medications and/or insulin
- A score equal to 25 on the Medication Adherence Rating Scale (MARS-5)
Trial locations and contacts
1 site in 1 country.
United States1 site
William S. Middleton Memorial Veterans Hospital
Madison, Wisconsin, 53705
About this study
This study uses an intervention mixed methods design. The overall purpose is to improve medication adherence and assess the clinical impact on diabetes outcomes among patients with uncontrolled diabetes. We will examine if usual care combined with a clinic-based health literacy/psychosocial support intervention improves medication adherence compared to usual care alone. A randomized controlled trial will be conducted at William S. Middleton Memorial Veterans Hospital in Madison, targeting individuals with uncontrolled diabetes. The patient-centered health literacy intervention will focus on enhancing patients' self-efficacy and addressing patients' negative beliefs in medicine and illness.
Read the detailed description
The study will improve medication adherence for patients with diabetes using two strategies: 1) addressing health literacy by reducing the complexity of diabetes content disseminated to patients during medication counseling and 2) addressing health literacy by enhancing patient-pharmacist communication. The second strategy aims to improve the psychosocial support offered to patients by building self-efficacy and addressing negative beliefs about medicines and diabetes. Together, the patient and the pharmacist can work together towards goal setting, problem solving, and negotiation of competing priorities.
Currently, with usual care, the pharmacist confirms if patients understand how to take medications correctly, adjusts diabetes medications, and monitor patients' hemoglobin A1C levels periodically to make sure that patients are capable of managing their diabetes appropriately. With the proposed intervention, the pharmacist will identify patients' concerns and barriers to medication taking and self-care with diabetes with an emphasis on self-efficacy, negative beliefs in medicine and illness. Then the pharmacist will provide individualized plans and set specific goals with each patient by strengthening their confidence in medication use and health literacy skills in navigating health information for diabetes self-care. The methods described for the intervention are in line with the current clinic workflow and will not require a substantial change to the current system for counseling diabetes patients. Knowledge change often does not lead to behavior change. Hence, the intervention will innovatively focus on moving knowledge towards action as the clinical pharmacist works with patients in assessing health literacy, identifying their barriers to medication use, including lack of self-efficacy, addressing negative beliefs about diabetes and diabetes medications; towards problem solving, and developing goals and action plans that will improve medication adherence and glycemic control.
- Conditions
- Diabetes Mellitus
- Being tested
- Health literacy-psychosocial support
- Keywords
- Health literacy, Self-efficacy, Beliefs about diabetes, Beliefs in medicines
- 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 literacy-psychosocial supportOther
The intervention is based upon enhancing patient health literacy-related attributes by (1) addressing the barriers to patients' self-efficacy by working with the patient to minimize the barriers (2) clarifying the patient beliefs about diabetes and diabetes medications, and (3) developing personalized action plans. We will tailor the intervention to each patient, so, the details of the content of each session will depend on the individual's self-efficacy, beliefs in illness and medicines, and health literacy level obtained at baseline. In addition to the 45-minute scheduled sessions, patients will be able to call the clinical pharmacist on the phone during the 6-week session at their discretion, for patient-driven support for self-management of goals and skills.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Receive usual care only. |
| Health literacy-psychosocial support | Experimental | Receive 6-week sessions of individual health literacy-psychosocial support in addition to usual care. The health literacy-psychosocial support intervention includes 45-minute face-to-face counseling at week 1 and week 6 as well as weekly phone calls (week 2 to week 5.) Receives: Other: Health literacy-psychosocial support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diabetes medication adherence
Proportion of days covered and the 5-item Medication Adherence Rating Scale (MARS-5) will be used to measure diabetes medication adherence. The minimum score for the MAR scale is 5 and the maximum score is 25. Total score ranges from 5-25; Higher scores represent higher self-reported adherence.
Measured: Baseline, 3 months, and 6 months after the intervention
Change in diabetes control
Hemoglobin A1c will be abstracted from electronic medical records using the most recent value for each participant within the prior six months.
Measured: Baseline and 6 months after the intervention
Secondary outcomes (5)
Self-efficacy for medication use
Self-efficacy for medication use will be measured using the 13-item Self-efficacy for Appropriate Medication Use Scale. The minimum score is 13 and the maximum score is 39. Higher scores represent higher confidence in adhering to medication use.
Measured: Baseline, 6 weeks, and 3 months after the intervention
Illness beliefs
Illness beliefs will be measured using the 9-item the Brief Illness Perception Questionnaire. A higher score indicates a more threatening view of the illness. Total score ranges from 0-80.
Measured: Baseline, 6 weeks, and 3 months after the intervention
Beliefs in medicines
Beliefs in medicines will be measured using the 10-item Belief about Medicines Questionnaire. The 10-item Belief about Medicines Questionnaire (BMQ) has the necessity beliefs and concern beliefs sub-scale (five items each). The scale has five-point Likert-type responses ranging from strongly disagree to strongly agree. Each sub-scale has scores ranging from 5-25, with a higher score meaning stronger concern or necessity beliefs about the medicine.
Measured: Baseline, 6 weeks, and 3 months after the intervention
Health literacy
Health literacy will be measured using the 6-item Newest Vital Sign. Each question will be scored "0" for incorrect and "1" for correct yielding a total score ranging from 0 to 6, with higher scores indicating better health literacy. Scores less than 2 represented a high likelihood (50% or more) of limited (inadequate) health literacy, 2 to 3 indicated the possibility of limited (marginal) health literacy, and more than 3 suggested adequate health literacy.
Measured: Baseline and 6 months after the intervention
Experiences and perceptions of the intervention processes and outcomes
A phenomenological qualitative approach using semi-structured 60-minute in-depth interviews will be conducted with 15 intervention participants.
Measured: 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start4 Dec 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
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 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, William S. Middleton Memorial Veterans Hospital
- Responsible party
- Sponsor
- Investigators
- Olayinka Shiyanbola, PhD, BPharm, Principal investigator, School of Pharmacy, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406923
- Sponsor's protocol ID
- 2017-0951
- Other IDs
- Protocol Version 3/27/2020, A561000, PHARM/PHARMACY
- Status last verified
- Feb 2021
- First submitted
- 28 Dec 2017
- Last updated
- 12 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Farmer KC. Methods for measuring and monitoring medication regimen adherence in clinical trials and clinical practice. Clin Ther. 1999 Jun;21(6):1074-90; discussion 1073. doi: 10.1016/S0149-2918(99)80026-5.
PubMed 10440628Keogh KM, Smith SM, White P, McGilloway S, Kelly A, Gibney J, O'Dowd T. Psychological family intervention for poorly controlled type 2 diabetes. Am J Manag Care. 2011 Feb;17(2):105-13.
PubMed 21473660Lee YJ, Shin SJ, Wang RH, Lin KD, Lee YL, Wang YH. Pathways of empowerment perceptions, health literacy, self-efficacy, and self-care behaviors to glycemic control in patients with type 2 diabetes mellitus. Patient Educ Couns. 2016 Feb;99(2):287-94. doi: 10.1016/j.pec.2015.08.021. Epub 2015 Sep 2.
PubMed 26341940Unni E, Shiyanbola OO, Farris KB. Change in Medication Adherence and Beliefs in Medicines Over Time in Older Adults. Glob J Health Sci. 2015 Sep 1;8(5):39-47. doi: 10.5539/gjhs.v8n5p39.
PubMed 26652095Shiyanbola OO, Farris KB, Chrischilles E. Concern beliefs in medications: changes over time and medication use factors related to a change in beliefs. Res Social Adm Pharm. 2013 Jul-Aug;9(4):446-57. doi: 10.1016/j.sapharm.2012.07.003. Epub 2012 Sep 19.
PubMed 22999805
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-efficacy, Beliefs and Adherence- Pilot and Feasibility Trial of a Pharmacist-led Intervention
- ClinicalTrials.gov ID
- NCT03406923
- Acronym / sponsor ID
- 2017-0951
- Conditions
- Diabetes Mellitus
- Keywords
- Health literacy, Self-efficacy, Beliefs about diabetes, Beliefs in medicines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, William S. Middleton Memorial Veterans Hospital
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 23 Jan 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.
This study uses an intervention mixed methods design. The overall purpose is to improve medication adherence and assess the clinical impact on diabetes outcomes among patients with uncontrolled diabetes. We will examine if usual care combined with a clinic-based health literacy/psychosocial support intervention improves medication adherence compared to usual care alone. A randomized controlled trial will be conducted at William S. Middleton Memorial Veterans Hospital in Madison, targeting individuals with uncontrolled diabetes. The patient-centered health literacy intervention will focus on enhancing patients' self-efficacy and addressing patients' negative beliefs in medicine and illness.
Detailed description
The study will improve medication adherence for patients with diabetes using two strategies: 1) addressing health literacy by reducing the complexity of diabetes content disseminated to patients during medication counseling and 2) addressing health literacy by enhancing patient-pharmacist communication. The second strategy aims to improve the psychosocial support offered to patients by building self-efficacy and addressing negative beliefs about medicines and diabetes. Together, the patient and the pharmacist can work together towards goal setting, problem solving, and negotiation of competing priorities.
Currently, with usual care, the pharmacist confirms if patients understand how to take medications correctly, adjusts diabetes medications, and monitor patients' hemoglobin A1C levels periodically to make sure that patients are capable of managing their diabetes appropriately. With the proposed intervention, the pharmacist will identify patients' concerns and barriers to medication taking and self-care with diabetes with an emphasis on self-efficacy, negative beliefs in medicine and illness. Then the pharmacist will provide individualized plans and set specific goals with each patient by strengthening their confidence in medication use and health literacy skills in navigating health information for diabetes self-care. The methods described for the intervention are in line with the current clinic workflow and will not require a substantial change to the current system for counseling diabetes patients. Knowledge change often does not lead to behavior change. Hence, the intervention will innovatively focus on moving knowledge towards action as the clinical pharmacist works with patients in assessing health literacy, identifying their barriers to medication use, including lack of self-efficacy, addressing negative beliefs about diabetes and diabetes medications; towards problem solving, and developing goals and action plans that will improve medication adherence and glycemic control.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Receive usual care only. |
| Health literacy-psychosocial support | Experimental | Other: Health literacy-psychosocial supportReceive 6-week sessions of individual health literacy-psychosocial support in addition to usual care. The health literacy-psychosocial support intervention includes 45-minute face-to-face counseling at week 1 and week 6 as well as weekly phone calls (week 2 to week 5.) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English-speaking men and women 18-80 years old with diabetes
- Taking oral diabetes medications and/or insulin
- One hemoglobin A1C measure of 8% or greater in the last 18 months
- A score less than 25 on the Medication Adherence Rating Scale (MARS-5)
Key exclusion criteria (5 listed)
- Unable to provide informed consent
- Younger than 18 years old or older than 80 years old
- Unable to understand English
- Do not take oral diabetes medications and/or insulin
- A score equal to 25 on the Medication Adherence Rating Scale (MARS-5)
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 literacy-psychosocial supportThe intervention is based upon enhancing patient health literacy-related attributes by (1) addressing the barriers to patients' self-efficacy by working with the patient to minimize the barriers (2) clarifying the patient beliefs about diabetes and diabetes medications, and (3) developing personalized action plans. We will tailor the intervention to each patient, so, the details of the content of each session will depend on the individual's self-efficacy, beliefs in illness and medicines, and health literacy level obtained at baseline. In addition to the 45-minute scheduled sessions, patients will be able to call the clinical pharmacist on the phone during the 6-week session at their discretion, for patient-driven support for self-management of goals and skills. | Other | Health literacy-psychosocial support |
Primary outcome
Change in diabetes medication adherence
Time frame: Baseline, 3 months, and 6 months after the intervention
Proportion of days covered and the 5-item Medication Adherence Rating Scale (MARS-5) will be used to measure diabetes medication adherence. The minimum score for the MAR scale is 5 and the maximum score is 25. Total score ranges from 5-25; Higher scores represent higher self-reported adherence.
Change in diabetes control
Time frame: Baseline and 6 months after the intervention
Hemoglobin A1c will be abstracted from electronic medical records using the most recent value for each participant within the prior six months.
5 secondary outcomes
Self-efficacy for medication use
Time frame: Baseline, 6 weeks, and 3 months after the intervention
Illness beliefs
Time frame: Baseline, 6 weeks, and 3 months after the intervention
Beliefs in medicines
Time frame: Baseline, 6 weeks, and 3 months after the intervention
Health literacy
Time frame: Baseline and 6 months after the intervention
Experiences and perceptions of the intervention processes and outcomes
Time frame: 6 months after the intervention
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 12 Feb 2021.
- Background: PubMed 10440628Farmer KC. Methods for measuring and monitoring medication regimen adherence in clinical trials and clinical practice. Clin Ther. 1999 Jun;21(6):1074-90; discussion 1073. doi: 10.1016/S0149-2918(99)80026-5.
- Background: PubMed 21473660Keogh KM, Smith SM, White P, McGilloway S, Kelly A, Gibney J, O'Dowd T. Psychological family intervention for poorly controlled type 2 diabetes. Am J Manag Care. 2011 Feb;17(2):105-13.
- Background: PubMed 26341940Lee YJ, Shin SJ, Wang RH, Lin KD, Lee YL, Wang YH. Pathways of empowerment perceptions, health literacy, self-efficacy, and self-care behaviors to glycemic control in patients with type 2 diabetes mellitus. Patient Educ Couns. 2016 Feb;99(2):287-94. doi: 10.1016/j.pec.2015.08.021. Epub 2015 Sep 2.
- Background: PubMed 26652095Unni E, Shiyanbola OO, Farris KB. Change in Medication Adherence and Beliefs in Medicines Over Time in Older Adults. Glob J Health Sci. 2015 Sep 1;8(5):39-47. doi: 10.5539/gjhs.v8n5p39.
- Background: PubMed 22999805Shiyanbola OO, Farris KB, Chrischilles E. Concern beliefs in medications: changes over time and medication use factors related to a change in beliefs. Res Social Adm Pharm. 2013 Jul-Aug;9(4):446-57. doi: 10.1016/j.sapharm.2012.07.003. Epub 2012 Sep 19.
- Individual participant dataSharing planned: No
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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.
Olayinka Shiyanbola, PhD, BPharm principal investigator
School of Pharmacy, University of Wisconsin, Madison
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 literacy-psychosocial support in people with Diabetes Mellitus, run by University of Wisconsin, Madison 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 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 12 Feb 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 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 diabetes medication adherence (time frame: Baseline, 3 months, and 6 months after the intervention). The study lists 2 primary outcomes in all. 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 NCT03406923, 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 12 Feb 2021.