N/A
Completed N=506
FAMS Mobile Health Intervention for Diabetes Self-care Support
Source: ClinicalTrials.gov NCT02481596 ↗Enrolled (actual)
506
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Adherence to Diet - Use of Dietary Information — 3.0; 3.3; 2.7; 3.3 score on a scale — p=.045
Summary
This study evaluates a family-focused mobile phone-delivered intervention, called FAMS (Family-focused Add-on for Motivating Self-care), in supporting adults with type 2 diabetes in their self-management relative to a control group. The goal of this study is to ascertain if family-focused content delivered to the patient can improve the patients' family support for diabetes self-care, self-efficacy, and adherence to diet and exercise recommendations.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence to Diet - Use of Dietary Information |
3.0; 3.3; 2.7; 3.3; 3.3; 2.7 | .045 sig |
| PRIMARY Adherence to Exercise |
1293; 1000; 1295; 1251; 977; 1187 | .518 |
| PRIMARY Adherence to Diet - Problem Eating Behavior |
3.3; 3.0; 3.0; 3.3; 3.0; 3.0 | .53 |
| SECONDARY Supportive Family Behaviors |
1.8; 1.6; 1.8; 1.8; 1.6; 1.7 | .024 sig |
| SECONDARY Obstructive Family Behaviors |
1.4; 1.4; 1.6; 1.3; 1.4; 1.4 | .001 sig |
| SECONDARY Diabetes Self-efficacy |
14; 15; 14; 15; 15; 14 | .015 sig |
Eligibility Criteria
*Note: Criteria for patient participants is consistent with larger study (NCT02409329).
Inclusion Criteria
- Adults aged 18 years and older
- Individuals who have received a diagnosis for type 2 diabetes mellitus
- Enrolled as a patient at a participating community health center
- Individuals currently being treated with oral and/or injectable diabetes medications
Exclusion Criteria
- Non-English speakers
- Individuals who report they do not have a cell phone
- Individuals unwilling and/or not able to provide written informed consent
- Individuals with unintelligible speech (e.g., dysarthria)
- Individuals with a severe hearing or visual impairment
- Individuals who report a caregiver administers their diabetes medications
- Individuals who fail the cognitive screener administered during the baseline survey
- Individuals who cannot receive, read, and respond to a text after instruction from a trained research assistant
Support persons invited to receive text messages must meet following criteria:
Support Person Inclusion Criteria:
- Adults aged 18 years and older
- Identified by the patient as a part of their family (can be related biologically or legally, or be a close friend/roommate who participates in the patients' daily routine)
Support Person Exclusion Criteria:
- Non-English speakers (determined subjectively by a trained research assistant)
- Individuals who report they do not have a cell phone
- Individuals unwilling and/or not able to provide written informed consent
- Individuals with unintelligible speech (e.g., dysarthria) (determined subjectively by a trained research assistant)
- Individuals with a severe hearing or visual impairment (determined subjectively by a trained research assistant)
Data sourced from ClinicalTrials.gov (NCT02481596). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.