Physical Disability, Type 2 Diabetes
Conditions
Brief summary
The purpose of this project is to develop, and pilot test an accessible and inclusive medical nutrition therapy and diabetes self-management education program for people with Type 2 Diabetes and physical disabilities.
Detailed description
This study will use a three-arm randomized control trial design. Eligible and consented participants will be assigned to one of three groups: (1) intervention with high-tech support, (2) intervention with low-tech support, and (3) attention-control group. The active intervention period will include six months of weekly health coaching calls and technology access. The low-tech support group will receive six months of weekly coaching calls and weekly email containing related materials in PDF format but no video and technology content.
Interventions
BEHAVIORALHigh-Tech
Access to technological platform and weekly health coaching
BEHAVIORALLow-Tech
Weekly email with educational content and weekly health coaching
BEHAVIORALAttention Control
No technology access or health coaching
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of T2DM 2. 18 to 65 years of age 3. Living with a permanent physical disability such as SCI, spina bifida, multiple sclerosis, stroke 4. Ability to converse in and read English 5. Availability of a smartphone or computer that can run apps 6. Have internet connection capabilities
Exclusion criteria
1. Current enrollment in any diabetes related intervention 2. Present or soon-planned pregnancy 3. Major heart attack or heart surgery in the past 12 months 4. Have undergone a dialysis, kidney transplant or a kidney surgery in the past 12 months 5. Severe cognitive impairment 6. Severe untreated depression in the past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Quality of Life | 24 weeks | Measured using the DQoL (Diabetes Quality of Life Measure) Questionnaire; Minimum score =1; maximum score = 5; Higher score represents worse outcome |
| Self-efficacy | 24 weeks | Measured using Diabetes Empowerment Scale; Minimum score = 1; maximum score = 5; Higher score represents better outcome |
| Psychological Distress | 234 weeks | Measured using Diabetes Distress Scale (DDS); Minimum score = 1, maximum score = 6; Higher score represents worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Management | 24 weeks | Measured using HbA1c |
Other
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity | 24 weeks | Measured using Godin leisure-time exercise questionnaire; Minimum score = 0; Maximum score = unknown; Higher score represents better outcome |
| Health Dashboard Usability | 24 weeks | Measured using the System Usability Scale; Maximum item score (Strongly agree) = 5, minimum item score (Strongly disagree) = 1; Higher scores represent better outcomes |
| Medication Adherence | 24 weeks | Measured using the Medication Adherence Rating Scale |
| Dietary intake | 24 weeks | Measured using The US version of the Diabetes and Diet Questionnaire |
Countries
United States
Outcome results
None listed