Peers LEAD Plus Healthy Living With Diabetes (HLWD)
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|ClinicalTrials.gov Identifier: NCT04857411|
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : April 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Behavioral: Peers LEAD plus HLWD||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Improving Diabetes Programs for Blacks in Wisconsin: Peers as Coaches in Medicine Use|
|Actual Study Start Date :||April 19, 2021|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Participant 'Buddies'
Participants will have an 8-week program initiation phase followed by a maintenance phase through 6-months, supported by Ambassadors.
Behavioral: Peers LEAD plus HLWD
Combined Peers LEAD and Healthy Living with Diabetes is a culturally-appropriate program to increase medication adherence
- Mean Hemoglobin A1c [ Time Frame: baseline ]Participant buddies will have a hemoglobin A1c greater than 8 percent at baseline. will be measured using the A1cNow+ system, the National Glycohemoglobin Standardization Program Certified, CLIA-waived, system that provides results using a finger stick test.
- Mean Hemoglobin A1c [ Time Frame: 3 months ]Participant buddies will have a hemoglobin A1c greater than 8 percent at baseline. will be measured using the A1cNow+ system, the National Glycohemoglobin Standardization Program Certified, CLIA-waived, system that provides results using a finger stick test.
- Mean Hemoglobin A1c [ Time Frame: 6 months ]Participant buddies will have a hemoglobin A1c greater than 8 percent at baseline. will be measured using the A1cNow+ system, the National Glycohemoglobin Standardization Program Certified, CLIA-waived, system that provides results using a finger stick test.
- Mean Systolic Blood Pressure [ Time Frame: baseline ]Blood pressure readings collected via the Omron Healthcare Inc. 7 Series Upper Arm Blood Pressure Monitor.
- Mean Systolic Blood Pressure [ Time Frame: 3 months ]Blood pressure readings collected via the Omron Healthcare Inc. 7 Series Upper Arm Blood Pressure Monitor.
- Mean Systolic Blood Pressure [ Time Frame: 6 months ]Blood pressure readings collected via the Omron Healthcare Inc. 7 Series Upper Arm Blood Pressure Monitor.
- Change in Diastolic Blood Pressure [ Time Frame: baseline, 3 months, 6 months ]
- Adherence to Reﬁlls and Medications Scale for Diabetes (ARMS-D) Score [ Time Frame: baseline, 3 months, 6 months ]ARMS-D is a measure of medication adherence. It is an 11-item survey with a total possible range of scores 11-44. Lower scores indicate better medication adherence.
- Self-Efficacy for Adherence to Medication Use Scale (SEAMS) [ Time Frame: baseline, 3 months, 6 months ]SEAMS is a 16-item questionnaire that assesses peoples' confidence in taking their medications correctly, which can be used to determine medication self-efficacy in a person with diabetes. Current evidence exists demonstrating the reliability and validity of the SEAMS instrument. Respondents are asked to indicate, under a number of different circumstances, their level of confidence about taking medications correctly. Each item is evaluated using a 3-point Likert-type scale (1 = not confident, 2 = somewhat confident, and 3 = very confident). The sum of SEAMS ranges from 13 to 39. Higher scores reflect that respondents have more confidence in being adherent to their medication use.
- Patient's Perceived Involvement in Care Scale (PICS) [ Time Frame: baseline, 3 months, 6 months ]
PICS is a brief, psychometrically-sound, self-report questionnaire about primary care patients' attitudes regarding their illnesses and the management of them. This instrument is designed to examine three relatively distinct factors: (1) doctor facilitation of patient involvement, (2) level of information exchange, and (3) patient participation in decision making.
This instrument evaluates doctor-patient interactions across three relatively distinct factors, including doctor facilitation of patient involvement (5 items), level of information exchange (4 items), and patient participation in decision making (4 items). In total, respondents answer 13 dichotomous items (0 point is given for "no" and 1 point for "yes.") Items scores are summed to generate a total score ranging from 0-13, and higher scores suggest a greater degree of shared decision making for disease self-management.
- Diabetes Distress Scale (DDS) 2 [ Time Frame: baseline, 3 months, 6 months ]The DDS-2 is a 2-item screener version of the reliable and valid 17-item DDS questionnaire, which is constructed for people with type 2 diabetes. The DDS-2 is a simple method to evaluate peoples' feelings about being overwhelmed by the demands of living with diabetes and about the extent that people believe that they are failing with their diabetes routine. Each item is evaluated using a 6-point scale (1 and 2 = not a problem, 3 and 4 = moderate problem, and 5 and 6 = serious problem) for a range of possible scores between 2 and 12. People who rate these two items higher are reporting a greater the degree to which diabetes-related distress is bothering them in their lives.
- Patient Health Questionnaire (PHQ-4) [ Time Frame: baseline, 3 months, 6 months ]PHQ-4 is an 4-item instrument that is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies, and also serves as a useful measure for the purpose of population-based studies. A score of 10 or greater is considered major depression, 20 or more is severe major depression.
- Diabetes Empowerment Scale - Short Form (DES-SF) [ Time Frame: baseline, 3 months, 6 months ]
The DES-SF is an 8-item short form of the original 37-item Diabetes Empowerment Scale. The DES-SF allows for a brief overall assessment of diabetes-related psychosocial self-efficacy. Investigations have provided preliminary evidence that the DES-SF is a valid and reliable measure of overall diabetes-related psychosocial self-efficacy.
An item checked "strongly agree" receives 5 points; "agree" - 4 points; "neutral" - 3 points; "disagree" - 2 points; and "strongly disagree" receives 1 point. The possible range of scores is 8-40, with higher scores indicating higher diabetes-related psychosocial self-efficacy.
- Brief Illness Perception Questionnaire (Brief IPQ) [ Time Frame: baseline, 3 months, 6 months ]
The Brief IPQ is a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. The Brief IPQ uses a single-item scale approach to assess perception on a 0-10 continuous linear response scale. Overall, the Brief IPQ is a psychometrically sound instrument that provides a rapid assessment of illness perceptions, and can be particularly helpful in ill populations, large-scale studies, and in repeated measures research designs.
To compute the score, reverse score items 3, 4, and 7 and add these to items 1, 2, 5, 6, and 8 for a range of scores from 0-80. A higher score reflects a more threatening view of the illness. Item 9 is qualitative and not scored with the other items. It asks respondents to list in rank-order the three most important factors they believe caused their illness.
- Beliefs about Medicines Questionnaire (BMQ) [ Time Frame: baseline, 3 months, 6 months ]
The BMQ is a tool for evaluating people's beliefs about the necessity of medications and concerns about using those medications. It has been validated for use in patients with chronic illnesses and has been shown to predict adherence to treatment among people with type 2 diabetes.
The BMQ has 10-items and consists of two 5-item subscales: necessity beliefs and concern beliefs. Each item is measured on 5-point Likert-type scales with 'strongly disagree (score = 1)' to 'strongly agree (score = 5)' response options. The scores summed for each subscale range from 5-25, with a higher score meaning stronger necessity or concern beliefs about the medication prescribed for personal use.
- Newest Vital Sign (NVS) [ Time Frame: baseline, 3 months, 6 months ]The NVS is a 6-item assessment of respondent's health literacy in the following areas: literacy, comprehension, application/function, evaluation, and numeracy skills. Each question is 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 of less than 2 represents high likelihood (50% or more) of limited (inadequate) literacy, 2 to 3 indicates possibility of limited (marginal) literacy, and more than 3 suggests adequate literacy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04857411
|Contact: Martha Maurer, MPH, PhDemail@example.com|
|United States, Wisconsin|
|Milwaukee, Wisconsin, United States, 53202|
|Contact: Martha Maurer 608-265-2662 firstname.lastname@example.org|
|Principal Investigator:||Olayinka Shiyanbola, PhD, B.Pharm||University of Wisconsin, Madison|