Trial Outcomes & Findings for Social Support Intervention for Older Adults With T2DM (NCT NCT04568486)

Last Updated: 2025-02-13

Results Overview

The change in participants' hemoglobin A1c measures will be abstracted from their medical records pre- and post-training with the DEEP program. Improved hemoglobin A1c figures suggest an overall success of the DEEP program and a better ability for patients to manage their diabetes.

Recruitment status

COMPLETED

Study phase

Target enrollment

90 participants

Primary outcome timeframe

12 months

Results posted on

2025-02-13

Participant Flow

Seeds: Older adults will be primarily recruited from the University of Kentucky (UK) Center of Excellence in Rural Health clinic. Alters: As a result of social network analysis of individual older adults (seeds), a member of the social network (alter) will be identified to participate in as a seed-alter dyad social support intervention. The seed and alter must be consented to participate in the intervention.

Participant milestones

Participant milestones
Measure	Rural-dwelling Older Adults (Seed) and Key Players (Alter Rural-dwelling older adults will be interviewed to map their social network structure, determine the types of social support provided by members of their social network, and identify key players within these networks. This group will be paired with their key players (identified during interviews) to receive the diabetes education. The pair complete the intervention as a dyad. Diabetes Empowerment Education Program: The Diabetes Empowerment Education Program (DEEP) is an education curriculum designed to help people with pre-diabetes, diabetes, relatives and caregivers gain a better understanding of diabetes self-care. Classes last a total of six weeks, providing participants with eight unique learning modules. Health literacy will be assessed before and after participating in DEEP.
Overall Study STARTED	90
Overall Study Seed	65
Overall Study Alter	25
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	33

Reasons for withdrawal

Reasons for withdrawal
Measure	Rural-dwelling Older Adults (Seed) and Key Players (Alter Rural-dwelling older adults will be interviewed to map their social network structure, determine the types of social support provided by members of their social network, and identify key players within these networks. This group will be paired with their key players (identified during interviews) to receive the diabetes education. The pair complete the intervention as a dyad. Diabetes Empowerment Education Program: The Diabetes Empowerment Education Program (DEEP) is an education curriculum designed to help people with pre-diabetes, diabetes, relatives and caregivers gain a better understanding of diabetes self-care. Classes last a total of six weeks, providing participants with eight unique learning modules. Health literacy will be assessed before and after participating in DEEP.
Overall Study Withdrawal by Subject	26
Overall Study Lost to Follow-up	7

Baseline Characteristics

number of participants with data collected for this demographic

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rural-dwelling Older Adults (Seed) and Key Players (Alter n=83 Participants Rural-dwelling older adults will be interviewed to map their social network structure, determine the types of social support provided by members of their social network, and identify key players within these networks. This group will be paired with their key players (identified during interviews) to receive the diabetes education. The pair complete the intervention as a dyad. Diabetes Empowerment Education Program: The Diabetes Empowerment Education Program (DEEP) is an education curriculum designed to help people with pre-diabetes, diabetes, relatives and caregivers gain a better understanding of diabetes self-care. Classes last a total of six weeks, providing participants with eight unique learning modules. Health literacy will be assessed before and after participating in DEEP.
Age, Continuous Seed	64.91 years STANDARD_DEVIATION 7.66 • n=60 Participants • number of participants with data collected for this demographic
Age, Continuous Alter	60.52 years STANDARD_DEVIATION 13.07 • n=23 Participants • number of participants with data collected for this demographic
Sex: Female, Male seed · Female	33 Participants n=57 Participants • number of participants with data collected for this demographic
Sex: Female, Male seed · Male	24 Participants n=57 Participants • number of participants with data collected for this demographic
Sex: Female, Male alter · Female	16 Participants n=23 Participants • number of participants with data collected for this demographic
Sex: Female, Male alter · Male	7 Participants n=23 Participants • number of participants with data collected for this demographic
Ethnicity (NIH/OMB) seed · Hispanic or Latino	0 Participants n=3 Participants • data only reported by 3 participants in the seed group and 1 participant in the alter group for this demographic
Ethnicity (NIH/OMB) seed · Not Hispanic or Latino	0 Participants n=3 Participants • data only reported by 3 participants in the seed group and 1 participant in the alter group for this demographic
Ethnicity (NIH/OMB) seed · Unknown or Not Reported	3 Participants n=3 Participants • data only reported by 3 participants in the seed group and 1 participant in the alter group for this demographic
Ethnicity (NIH/OMB) alter · Hispanic or Latino	1 Participants n=1 Participants • data only reported by 3 participants in the seed group and 1 participant in the alter group for this demographic
Ethnicity (NIH/OMB) alter · Not Hispanic or Latino	0 Participants n=1 Participants • data only reported by 3 participants in the seed group and 1 participant in the alter group for this demographic
Ethnicity (NIH/OMB) alter · Unknown or Not Reported	0 Participants n=1 Participants • data only reported by 3 participants in the seed group and 1 participant in the alter group for this demographic
Race (NIH/OMB) seed · American Indian or Alaska Native	0 Participants n=57 Participants • number of participants reporting this demographic
Race (NIH/OMB) seed · Asian	0 Participants n=57 Participants • number of participants reporting this demographic
Race (NIH/OMB) seed · Native Hawaiian or Other Pacific Islander	0 Participants n=57 Participants • number of participants reporting this demographic
Race (NIH/OMB) seed · Black or African American	7 Participants n=57 Participants • number of participants reporting this demographic
Race (NIH/OMB) seed · White	46 Participants n=57 Participants • number of participants reporting this demographic
Race (NIH/OMB) seed · More than one race	0 Participants n=57 Participants • number of participants reporting this demographic
Race (NIH/OMB) seed · Unknown or Not Reported	4 Participants n=57 Participants • number of participants reporting this demographic
Race (NIH/OMB) alter · American Indian or Alaska Native	0 Participants n=22 Participants • number of participants reporting this demographic
Race (NIH/OMB) alter · Asian	0 Participants n=22 Participants • number of participants reporting this demographic
Race (NIH/OMB) alter · Native Hawaiian or Other Pacific Islander	0 Participants n=22 Participants • number of participants reporting this demographic
Race (NIH/OMB) alter · Black or African American	1 Participants n=22 Participants • number of participants reporting this demographic
Race (NIH/OMB) alter · White	21 Participants n=22 Participants • number of participants reporting this demographic
Race (NIH/OMB) alter · More than one race	0 Participants n=22 Participants • number of participants reporting this demographic
Race (NIH/OMB) alter · Unknown or Not Reported	0 Participants n=22 Participants • number of participants reporting this demographic
Region of Enrollment United States	83 participants n=83 Participants

PRIMARY outcome

Timeframe: 12 months

Population: only seed data are reported for this outcome; number of participants measured for this outcome at each time point (56, 21, and 7 respectively)

Outcome measures

Outcome measures
Measure	Rural-dwelling Older Adults (Seed) and Key Players (Alter n=60 Participants Rural-dwelling older adults will be interviewed to map their social network structure, determine the types of social support provided by members of their social network, and identify key players within these networks. This group will be paired with their key players (identified during interviews) to receive the diabetes education. The pair complete the intervention as a dyad. Diabetes Empowerment Education Program: The Diabetes Empowerment Education Program (DEEP) is an education curriculum designed to help people with pre-diabetes, diabetes, relatives and caregivers gain a better understanding of diabetes self-care. Classes last a total of six weeks, providing participants with eight unique learning modules. Health literacy will be assessed before and after participating in DEEP.
Hemoglobin A1c Baseline	7.004 percentage of hemoglobin Standard Deviation 1.19
Hemoglobin A1c 6 months	6.24 percentage of hemoglobin Standard Deviation 1.19
Hemoglobin A1c 12 months	6.47 percentage of hemoglobin Standard Deviation 1.05

SECONDARY outcome

Timeframe: 12 months

Population: only seed data are reported for this outcome; participants with data for the outcome measure at each time point (58, 21, and 7 respectively)

Participants' systolic and diastolic blood pressures will be abstracted from their medical records pre- and post-training with the DEEP program. Improved blood pressure outcomes suggest an overall success of the DEEP program and a better ability for patients to manage their diabetes.

Outcome measures

Outcome measures
Measure	Rural-dwelling Older Adults (Seed) and Key Players (Alter n=60 Participants Rural-dwelling older adults will be interviewed to map their social network structure, determine the types of social support provided by members of their social network, and identify key players within these networks. This group will be paired with their key players (identified during interviews) to receive the diabetes education. The pair complete the intervention as a dyad. Diabetes Empowerment Education Program: The Diabetes Empowerment Education Program (DEEP) is an education curriculum designed to help people with pre-diabetes, diabetes, relatives and caregivers gain a better understanding of diabetes self-care. Classes last a total of six weeks, providing participants with eight unique learning modules. Health literacy will be assessed before and after participating in DEEP.
Systolic Blood Pressure Baseline	127.59 mmHg Standard Deviation 15.23
Systolic Blood Pressure 6 months	129.57 mmHg Standard Deviation 17.82
Systolic Blood Pressure 12 months	129.71 mmHg Standard Deviation 15.07

SECONDARY outcome

Timeframe: 12 months

Population: only seed data are reported for this outcome; participants with data for the outcome measure at each time point (58, 21, and 7 respectively)

Outcome measures

Outcome measures
Measure	Rural-dwelling Older Adults (Seed) and Key Players (Alter n=60 Participants Rural-dwelling older adults will be interviewed to map their social network structure, determine the types of social support provided by members of their social network, and identify key players within these networks. This group will be paired with their key players (identified during interviews) to receive the diabetes education. The pair complete the intervention as a dyad. Diabetes Empowerment Education Program: The Diabetes Empowerment Education Program (DEEP) is an education curriculum designed to help people with pre-diabetes, diabetes, relatives and caregivers gain a better understanding of diabetes self-care. Classes last a total of six weeks, providing participants with eight unique learning modules. Health literacy will be assessed before and after participating in DEEP.
Diastolic Blood Pressure 6 months	77.42 mmHg Standard Deviation 7.46
Diastolic Blood Pressure Baseline	73.59 mmHg Standard Deviation 11.97
Diastolic Blood Pressure 12 months	77.28 mmHg Standard Deviation 10.59

SECONDARY outcome

Timeframe: 6 weeks

Population: Lipid measures were to be done either using electronic medical records or with a point-of-care (fingerstick) device. Due to HIPAA concerns during IRB approval, investigators decided to rely fully on the fingerstick approach to measuring lipids rather than medical records. At study start up, the fingerstick device intended for use was no longer available for purchase. Therefore, lipids were not collected as part of the study.

Participants' lipids measures will be abstracted from their medical records pre- and post-training with the DEEP program. Improved lipids outcomes suggest an overall success of the DEEP program and a better ability for patients to manage their diabetes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: only seed data are reported for this outcome; participants with data for the outcome measure at each time point (59, 20, and 7 respectively)

The Diabetes self-care management questionnaire consist of 16 questions and sum score was calculated by adding all 16 items. Sum scaled score was computed as actual sum of items/ maximum possible sum of items \* 10. The transformed score ranged from 0-10. Higher scores indicating better self-management

Outcome measures

Outcome measures
Measure	Rural-dwelling Older Adults (Seed) and Key Players (Alter n=60 Participants Rural-dwelling older adults will be interviewed to map their social network structure, determine the types of social support provided by members of their social network, and identify key players within these networks. This group will be paired with their key players (identified during interviews) to receive the diabetes education. The pair complete the intervention as a dyad. Diabetes Empowerment Education Program: The Diabetes Empowerment Education Program (DEEP) is an education curriculum designed to help people with pre-diabetes, diabetes, relatives and caregivers gain a better understanding of diabetes self-care. Classes last a total of six weeks, providing participants with eight unique learning modules. Health literacy will be assessed before and after participating in DEEP.
Self-care Baseline	6.93 score on a scale Standard Deviation 1.50
Self-care 6 montns	8.08 score on a scale Standard Deviation 1.03
Self-care 12 months	8.75 score on a scale Standard Deviation 1.13

SECONDARY outcome

Timeframe: 12 months

Population: only seed data are reported for this outcome; participants with data for the outcome measure at each time point (58, 20, and 7 respectively)

Participants' medication adherence will be measured from the Brooks Medication Adherence Scale. It measures medication adherence and consists of 6 questions. The total score ranged from 0-6. Less score is associated with being adherent to the medication.

Outcome measures

Outcome measures
Measure	Rural-dwelling Older Adults (Seed) and Key Players (Alter n=60 Participants Rural-dwelling older adults will be interviewed to map their social network structure, determine the types of social support provided by members of their social network, and identify key players within these networks. This group will be paired with their key players (identified during interviews) to receive the diabetes education. The pair complete the intervention as a dyad. Diabetes Empowerment Education Program: The Diabetes Empowerment Education Program (DEEP) is an education curriculum designed to help people with pre-diabetes, diabetes, relatives and caregivers gain a better understanding of diabetes self-care. Classes last a total of six weeks, providing participants with eight unique learning modules. Health literacy will be assessed before and after participating in DEEP.
Medication Adherence Baseline	0.84 score on a scale Standard Deviation 1.06
Medication Adherence 6 months	0.60 score on a scale Standard Deviation 0.75
Medication Adherence 12 months	0.57 score on a scale Standard Deviation 0.78

SECONDARY outcome

Timeframe: 12 months

Population: only seed data are reported for this outcome; participants with data for the outcome measure at each time point (57, 20, and 7 respectively)

Participants' overall quality of life will be measured with a validated quality of life measure (EuroQol-5D) along 5 dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The Euro Quality of life questionnaire used 5 questions. The total score was computed by adding the responses for all 5 questions. The total scores ranged from 5 -25. Higher scores is associated with poor quality of life.

Outcome measures

Outcome measures
Measure	Rural-dwelling Older Adults (Seed) and Key Players (Alter n=57 Participants Rural-dwelling older adults will be interviewed to map their social network structure, determine the types of social support provided by members of their social network, and identify key players within these networks. This group will be paired with their key players (identified during interviews) to receive the diabetes education. The pair complete the intervention as a dyad. Diabetes Empowerment Education Program: The Diabetes Empowerment Education Program (DEEP) is an education curriculum designed to help people with pre-diabetes, diabetes, relatives and caregivers gain a better understanding of diabetes self-care. Classes last a total of six weeks, providing participants with eight unique learning modules. Health literacy will be assessed before and after participating in DEEP.
Health-related Quality of Life Measures Baseline	9.45 score on a scale Standard Deviation 3.07
Health-related Quality of Life Measures 6 months	9.20 score on a scale Standard Deviation 3.33
Health-related Quality of Life Measures 12 months	9.14 score on a scale Standard Deviation 2.67

Adverse Events

Rural-dwelling Older Adults (Seed) and Key Players (Alter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brittany Smalls

University of Kentucky

Phone: 859-323-4916

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place