Type 2 Diabetes
Conditions
Brief summary
This is a two arm, pilot randomized control trial (RCT) in which 60 African American women (AAW), 40-64 years of age, with HbA1c ≥8% and multi-caregiving responsibilities will be recruited from communities in Milwaukee, Wisconsin and randomized to either: 1) an individual-based, social support, health educator-facilitated intervention to address multi-caregiving responsibilities (n=30), or 2) individual-based, health educator-facilitated diabetes education and skills training and general health education (n=30). All sessions will be delivered via telephone (i.e., landline, mobile device, smart device, etc.) by a health educator (i.e., nurse, social worker, Master's trained health educator) and is comprised of 12 weekly sessions and 3 booster sessions. Each session will last up to 60min. All study assessments will be administered by a Program Assistant at baseline, 3-months, and 6-months.
Detailed description
The investigators propose to test the feasibility and preliminary efficacy of this multi-caregiving intervention on improving outcomes among AAW, ages 40-64 years with type 2 diabetes (T2DM) and multi-caregiving responsibilities using a pilot randomized design compared to diabetes enhanced usual care. The goals of the study will be assessed under the following specific aims: Aim 1: To determine the feasibility of the multi-caregiving intervention as measured by recruitment, session attendance, retention, and treatment adherence in AAW with T2DM Aim 2: To test the preliminary efficacy of the multi-caregiving intervention on glycemic and blood pressure control in AAW with T2DM compared to individual-delivered, health-educator led diabetes enhanced usual care at 6 months Hypothesis 1: AAW who receive the multi-caregiving intervention will have significant reductions in hemoglobin A1c at 6 months compared to AAW who receive diabetes enhanced usual care Hypothesis 2: AAW who receive the multi-caregiving intervention will have significant reductions in blood pressure at 6 months compared to AAW who receive diabetes enhanced usual care Aim 3: To test the preliminary efficacy of the multi-caregiving intervention on self-care behaviors and quality of life in AAW with T2DM compared to individual-delivered, health educator led diabetes enhanced usual care at 6 months Hypothesis 1: AAW who receive the multi-caregiving intervention will have significant improvements in self-care behaviors (diet, physical activity, medication adherence, and blood glucose monitoring) at 6 months compared to AAW who receive diabetes enhanced usual care Hypothesis 2: AAW who receive the multi-caregiving intervention will have significant improvements in quality of life (SF-12 scores) at 6 months compared to AAW who receive diabetes enhanced usual care In the final 6-month assessment, study participants will be asked to participate in 30 to 40-minute, semi-structured interviews by telephone. Findings will help refine the intervention and emphasize elements that enhance participant uptake and motivation for sustained behavior change for the future R01.
Interventions
BEHAVIORALMulti-Caregiving Intervention
The multi-caregiving intervention consists of individual-based, social support, and health educator facilitation and includes: a. Storytelling/sharing of experiences (5 minutes); social support and problem solving (15 minutes); Coping strategies (15 minutes); and Structured Diabetes Education and Skills Training (15 minutes). The last 5 minutes will be used to debrief and review goals.
BEHAVIORALDiabetes Enhanced Usual Care Intervention
This is composed of individual-based, health educator-facilitated diabetes education and skills training and general health education and will receive structured diabetes education and skills training as described above (30 minutes) and an additional discussion on general health topics (i.e., back pain, dyspepsia, etc.) (30 minutes).
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Age 40-64 years * Self-identifies as female * Self-identifies as African American or Non-Hispanic Black * Self-reports multi-caregiving responsibilities * Clinical diagnosis of T2DM based on HbA1c≥8% at the screening/baseline assessment * Able to communicate in English * Access to a telephone (i.e., landline, mobile device, smart device, etc.)
Exclusion criteria
* Mental confusion at screening/baseline assessment suggesting significant dementia, active psychosis, or acute mental disorder * Participation in other diabetes trials * Life expectancy \<6 months based on screening questionnaire
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in HbA1c% From Baseline to 6 Months | Baseline, 6-months | Trained personnel collected 100cc of blood via venipuncture to measure hemoglobin A1c (HbA1c). All collections were performed in the community at a location convenient for the study participant. At the screening visit, the HbA1c had to be 8% or greater to be eligible for participation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Activity From Baseline to 6 Months | Screening/Baseline, 3-months, 6-months | Physical activity was measured using the 7-item International Physical Activity Questionnaire (IPAQ) that asks about physical activities over the last 7 days. The minimum and maximum values can vary; however, IPAQ provides ranges for physical activity in MET-minutes per week (MET-min/wk). MET-min/wk: The primary unit, calculated by multiplying minutes per week by the MET value (e.g., walking=3.3, moderate=4.0, vigorous=8.0). Low: No activity or not meeting moderate/high criteria. Moderate: Meeting criteria like 3+ days vigorous activity (≥20 min/day) OR 5+ days moderate/walking (≥30 min/day) OR 5+ days combined (≥600 MET-min/wk). High: Meeting criteria like 3+ days vigorous activity (≥1500 MET-min/wk) OR 7+ days combined (≥3000 MET-min/wk). |
| Change in Blood Pressure Control From Baseline to 6 Months | Screening/Baseline, 3-months, 6-months | Blood pressure measurements were obtained by the nurse/health educator using an automated BP monitor with participants seated comfortably for 5 minutes prior to the measurements. |
| Change in Blood Glucose Monitoring From Baseline to 6 Months | Screening/Baseline, 3-months, 6-months | Blood glucose monitoring was assessed with the previously validated Summary of Diabetes Self-Care Activities (SDSCA) scale, where scores are calculated for each of the five areas assessed by the SDSCA over the past 7 days: diet, exercise, blood glucose monitoring, foot care, and smoking status. Higher scores mean more engagement in self-care behaviors. |
| Change in Medication Adherence From Baseline to 6 Months | Screening/Baseline, 3-months, 6-months | Medication adherence was measured with the 6-item validated self-report Brooks Medication Adherence Scale. Each question asks yes-no questions about adherence, where a "no" response indicates better adherence. |
| Change in Health Related Quality of Life From Baseline to 6 Months | Screening/Baseline, 3-months, 6-months | The SF-12 is a valid and reliable instrument that was used to measure functional status and yielded summary physical (PCS-12) and mental health (MCS-12) outcome scores. Summary scores range from 0 to 100 where higher scores mean better quality of life. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJoni Williams, MD, MPH
Medical College of Wisconsin
Participant flow
Recruitment details
Recruitment occurred through community outreach and engagement in collaboration with community partners. Study information, eligibility criteria, and contact information for study personnel were detailed in correspondence materials of community partners and their affiliated networks. The recruitment flyer was displayed prominently in locations throughout the community. Self-referral/word-of-mouth was encouraged in response to recruitment flyers, the snowball method, and study advertisements.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 54 years |
| Glycemic Control (Measured by HbA1c) | 9.90 % |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 60 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 31 |
| other Total, other adverse events | 0 / 29 | 0 / 31 |
| serious Total, serious adverse events | 0 / 29 | 0 / 31 |
Outcome results
None listed