Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Rural Intervention for Caregivers' Heart Health (RICHH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03068390
Recruitment Status : Recruiting
First Posted : March 1, 2017
Last Update Posted : August 1, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Debra Moser, University of Kentucky

Brief Summary:

The investigators are testing a two-group, randomized, controlled trial with 280 primary caregivers of adult patients with a chronic illness to test the efficacy of the Rural Intervention for Caregivers' Heart Health (RICHH). Immediate (4-month) and long-term (12-month) effects of the RICHH intervention on CVD risk factors, self-management behaviors, and depressive symptoms will be compared to usual care. The investigators also will test the moderating effect of gender on intervention outcomes, given the many differences between male and female caregivers.

Specific Aim 1: To determine effects of the RICHH intervention on the primary outcomes of CVD risk factors (i.e., lipid profile, body mass index, and blood pressure) at 4 and 12 months.

Hypotheses 1: The intervention group will have better lipid profile, body mass index, and blood pressure outcomes than the usual care group at 4 and 12 months.

Specific Aim 2: To determine effects of the RICHH intervention on self-management behaviors (i.e., diet quality, physical activity level, and self-report adherence to specific CVD health behaviors).

Hypotheses 2: The intervention group will have better diet quality, higher physical activity levels, and better adherence to specific CVD health behaviors than the usual care group at 4 and 12 months.

Specific Aim 3: To determine effects of RICHH on depressive symptoms at 4 and 12 months.

Hypotheses 3: Caregivers receiving the intervention will have lower levels of depressive symptoms than caregivers receiving usual care at 4 and 12 months.

Specific Aim 4: To evaluate whether intervention effects on outcomes will differ by caregivers' gender.

Hypotheses 4: Effects will be stronger for male compared to female caregivers at 4 and 12 months.

Impact: The proposed study will have a substantial impact on caregivers' cardiovascular health and quality of life because it will provide needed CVD risk prevention, and health promotion to rural caregivers living in distressed environments where CVD risk reduction and self-management is difficult. The intervention holds the potential to produce major improvements in health among caregivers living in rural environments in the US.


Condition or disease Intervention/treatment Phase
Cardiovascular Risk Factor Behavioral: RICHH Intervention Behavioral: Usual care Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 group randomized controlled trial
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Rural Intervention for Caregivers' Heart Health (RICHH)
Actual Study Start Date : February 24, 2017
Estimated Primary Completion Date : August 21, 2021
Estimated Study Completion Date : August 21, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: RICHH Intervention
The RICHH intervention is an educational-behavioral and counseling intervention that promotes caregivers' knowledge, skills and motivation to engage in CVD risk reduction. The intervention is delivered individually to caregivers in their homes using video-conferencing technology on mini-iPads that we provide for all participants. Participants keep the mini-iPads at the end of the study. The program consists of 12 weekly sessions [30-45 minutes] followed by 8 bi-weekly [every other week] booster sessions and 6 monthly booster sessions that will be held at the caregivers' preferred times using a video conferencing program. A cardiac psychiatric advanced practice nurse certified cognitive behavioral therapy will deliver the intervention.
Behavioral: RICHH Intervention
Whole health cardiovascular disease (CVD) self-care risk reduction intervention

Active Comparator: Usual care
The usual care control group will receive an attention placebo intervention in which the caregivers will receive mini-iPads loaded with Caregiver and CVD risk reduction pamphlets in PDF format along with the associated links from the American Heart Association. Because the investigators may identify CVD risk factors in baseline testing in participants who do not know they have them, it would be unethical not to provide at least usual care for these. Thus, all individuals enrolled in the study and in whom the investigators identify CVD risk factors will receive referral to a primary care provider for management of the CVD risk factors identified.
Behavioral: Usual care
Referral to primary care provider




Primary Outcome Measures :
  1. Change in Lipid Profile Derived from point-of-care testing [ Time Frame: Baseline, 4 and 12 months ]
    lipid profile from point-of-care testing

  2. Change in Body Mass Index (kg/m2) calculated from height and weight [ Time Frame: Baseline, 4 and 12 months ]
    body mass index calculated from height and weight

  3. Change in Blood Pressure in mmHg [ Time Frame: Baseline, 4 and 12 months ]
    blood pressure


Secondary Outcome Measures :
  1. Change in Diet Quality measured by the Food Frequency Questionnaire [ Time Frame: Baseline, 4 and 12 months ]
    diet quality

  2. Change in Depressive Symptoms [ Time Frame: Baseline, 4 and 12 months ]
    depressive symptoms measured using PHQ-9

  3. Change in Physical Activity Level (steps per 24 hours) measured by actigraphy [ Time Frame: Baseline, 4 and 12 months ]
    physical activity levels assessed using Withings actigraph

  4. Change in Adherence measured using the Specific Adherence Scale score from Medical Outcomes Study [ Time Frame: Baseline, 4 and 12 months ]
    adherence using Specific Adherence Scale from Medical Outcomes Study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • primary family rural caregiver of patients with chronic illnesses
  • provided care for the patient for > 6 months
  • no cognitive impairment that would preclude understanding the consent process

Exclusion Criteria:

  • chronic drug abuse
  • current active cancer
  • any physical or emotional impairment that limits participants' abilities to engage in self-management or that is likely to result in needing a caregiver in the next 12 months.

Information from the National Library of Medicine

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): NCT03068390


Contacts
Layout table for location contacts
Contact: Debra K Moser, PhD 859-323-6687 dmoser@uky.edu

Locations
Layout table for location information
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40535
Contact: Debra K Moser, PhD, RN    859-323-6687    dmoser@uky.edu   
Contact: Theresa Back, MS, MN    859-323-6656    tback@uky.edu   
Principal Investigator: Debra K Moser, PhD, RN         
Sponsors and Collaborators
Debra Moser
National Institute of Nursing Research (NINR)
Investigators
Layout table for investigator information
Principal Investigator: Debra K Moser, PhD University of Kentucky

Layout table for additonal information
Responsible Party: Debra Moser, Sponsor/PI, University of Kentucky
ClinicalTrials.gov Identifier: NCT03068390     History of Changes
Other Study ID Numbers: 1R01NR016824 ( U.S. NIH Grant/Contract )
1R01NR016824 ( U.S. NIH Grant/Contract )
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No