Promoting Medication Adherence Among Older Adults With Hypertension
Overcoming Immunity to Change: A Feasibility Study of a New Method to Promote Medication Adherence Among Older Adults With Hypertension
Over 70% of US adults 65 or older are diagnosed with hypertension, the leading cause of cardiovascular disease and premature deaths in the world. Despite availability of effective drugs to control blood pressure, uncontrolled blood pressure and low adherence to antihypertensive drugs persist as major public health and clinical challenges. On average, 50% of adults adhere to chronic disease medications and lower levels of adherence are associated with worse blood pressure control and adverse outcomes. Many barriers to adherence are well known and have been targeted in interventions to improve medication adherence. As of yet, no single intervention has emerged as superior or even particularly effective in improving adherence. The investigators have recently identified unconscious, self-protective 'hidden motives' that contribute to nonadherence to chronic disease medications. There is a critical need to expand on this insight to test the potential for targeting individuals' 'hidden motives' for low adherence using an innovative learning process called Immunity-to-Change.
As a critical step in testing this intervention to target these 'hidden motives', the investigators will undertake a pilot study to assess the feasibility and acceptability of the Overcoming Immunity-to-Change intervention and determine effect sizes of the intervention on adherence, blood pressure (BP) control, and quality of life (QOL). The investigators will test the Immunity-to-Change intervention in a sample of nonadherent older adults with hypertension (n=18). Another sample of nonadherent older adults with hypertension will be monitored for comparison (n=18).
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Louisiana
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New Orleans, Louisiana, 미국, 70112
- Tulane University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Men and women ages 55 and older, with the goal of a sex- and race-balanced sample
- Diagnosis of essential hypertension
- Uncontrolled hypertension
- Current treatment with antihypertensive medication
- Low antihypertensive pharmacy refill
- English speaking
- Telephone access
- Ability to read print on a computer screen and use the computer keyboard
- Written consent to participate and HIPAA authorization
- Written acceptance of study contract
- Approval of health care provider
Exclusion Criteria:
- Cognitive impairment
- Enrollment in another clinical trial
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 평소 케어
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실험적: Health coaching
Two-hour in-person group counseling session led by health coach, involving development of personalized immunity maps that lay out adherence goal, behaviors that distract from goal, hidden motives that compete with achieving goal, and underlying assumptions Eight 50-minute individual telephone counseling sessions every three weeks with a health coach, focusing on uncovering hidden motives and challenging assumptions with the goal of overturning nonadherence mindsets |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in medication adherence (PDC)
기간: Baseline to 6 months
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Change in proportion of days covered (PDC) from baseline to 6 months
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Baseline to 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in medication adherence (MMAS-8)
기간: Baseline to 6 months
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Change in MMAS-8 score from baseline to 6 months
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Baseline to 6 months
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Change in medication adherence (KWood-4)
기간: Baseline to 6 months
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Change in KWood-4 score from baseline to 6 months
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Baseline to 6 months
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Change in medication adherence (MMAS-8)
기간: Baseline to 3 months
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Change in MMAS-8 score from baseline to 3 months
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Baseline to 3 months
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Change in medication adherence (KWood-4)
기간: Baseline to 3 months
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Change in KWood-4 score from baseline to 3 months
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Baseline to 3 months
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Change in proportion with low adherence (PDC)
기간: Baseline to 6 months
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Change in proportion with low adherence (PDC<0.8)
from baseline to 6 months
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Baseline to 6 months
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Change in proportion with low adherence (MMAS-8)
기간: Baseline to 6 months
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Change in proportion with low adherence (MMAS-8<6) from baseline to 6 months
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Baseline to 6 months
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Change in proportion with low adherence (KWood-4)
기간: Baseline to 6 months
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Change in proportion with low adherence (KWood-4>0) from baseline to 6 months
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Baseline to 6 months
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Change in proportion with low adherence (MMAS-8)
기간: Baseline to 3 months
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Change in proportion with low adherence (MMAS-8<6) from baseline to 3 months
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Baseline to 3 months
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Change in proportion with low adherence (KWood-4)
기간: Baseline to 3 months
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Change in proportion with low adherence (KWood-4>0) from baseline to 3 months
|
Baseline to 3 months
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Change in systolic blood pressure
기간: Baseline to 6 months
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Change in systolic blood pressure from baseline to 6 months
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Baseline to 6 months
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Change in diastolic blood pressure
기간: Baseline to 6 months
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Change in diastolic blood pressure from baseline to 6 months
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Baseline to 6 months
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Change in systolic blood pressure
기간: Baseline to 3 months
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Change in systolic blood pressure from baseline to 3 months (if available from insurance records)
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Baseline to 3 months
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Change in diastolic blood pressure
기간: Baseline to 3 months
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Change in diastolic blood pressure from baseline to 3 months (if available from insurance records)
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Baseline to 3 months
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Change in proportion with controlled blood pressure
기간: Baseline to 6 months
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Change in proportion with controlled blood pressure (SBP<140 & DBP<90) from baseline to 6 months
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Baseline to 6 months
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Change in proportion with controlled blood pressure
기간: Baseline to 3 months
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Change in proportion with controlled blood pressure (SBP<140 & DBP<90) from baseline to 3 months
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Baseline to 3 months
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Change in health-related quality of life
기간: Baseline to 6 months
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Change in health-related quality of life score (SF-36) from baseline to 6 months
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Baseline to 6 months
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Change in health-related quality of life
기간: Baseline to 3 months
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Change in health-related quality of life score (SF-36) from baseline to 3 months
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Baseline to 3 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in hidden motives score
기간: Baseline to 6 months
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Change in hidden motives score from baseline to 6 months
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Baseline to 6 months
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Change in hidden motives score
기간: Baseline to 3 months
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Change in hidden motives score from baseline to 3 months
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Baseline to 3 months
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Change in explicit attitudes score
기간: Baseline to 6 months
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Change in explicit attitudes score (Beliefs about Medicines Questionnaire) from baseline to 6 months
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Baseline to 6 months
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Change in explicit attitudes score
기간: Baseline to 3 months
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Change in explicit attitudes score (Beliefs about Medicines Questionnaire) from baseline to 3 months
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Baseline to 3 months
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Change in implicit attitudes score
기간: Baseline to 6 months
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Change in implicit attitudes score (d-score from single-category implicit association test) from baseline to 6 months
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Baseline to 6 months
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Change in explicit ambivalence score
기간: Baseline to 6 months
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Change in explicit ambivalence score (absolute value of difference between standardized positive and negative explicit attitudes scores) from baseline to 6 months
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Baseline to 6 months
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Change in explicit ambivalence score
기간: Baseline to 3 months
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Change in explicit ambivalence score (absolute value of difference between standardized positive and negative explicit attitudes scores) from baseline to 3 months
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Baseline to 3 months
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Change in implicit ambivalence score
기간: Baseline to 6 months
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Change in implicit ambivalence score (absolute value of difference between standardized explicit and implicit attitude scores)
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Baseline to 6 months
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Change in short risk aversion switch point
기간: Baseline to 6 months
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Change in short switch point on risk aversion scale from baseline to 6 months
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Baseline to 6 months
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Change in short risk aversion switch point
기간: Baseline to 3 months
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Change in short switch point on risk aversion scale from baseline to 3 months
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Baseline to 3 months
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Change in long risk aversion switch point
기간: Baseline to 6 months
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Change in long switch point on risk aversion scale from baseline to 6 months
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Baseline to 6 months
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Change in long risk aversion switch point
기간: Baseline to 3 months
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Change in long switch point on risk aversion scale from baseline to 3 months
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Baseline to 3 months
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Change in risk valuation
기간: Baseline to 6 months
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Change in value indicated on risk aversion scale from baseline to 6 months
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Baseline to 6 months
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Change in risk valuation
기간: Baseline to 3 months
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Change in value indicated on risk aversion scale from baseline to 3 months
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Baseline to 3 months
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Change in medication-taking self-efficacy (MUSE)
기간: Baseline to 6 months
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Change in score on MUSE medication-taking subscale from baseline to 6 months
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Baseline to 6 months
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Change in medication-taking self-efficacy (MUSE)
기간: Baseline to 3 months
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Change in score on MUSE medication-taking subscale from baseline to 3 months
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Baseline to 3 months
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Change in learning-about-medications self-efficacy (MUSE)
기간: Baseline to 6 months
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Change in score on MUSE learning-about-medications subscale from baseline to 6 months
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Baseline to 6 months
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Change in learning-about-medications self-efficacy (MUSE)
기간: Baseline to 3 months
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Change in score on MUSE learning-about-medications subscale from baseline to 3 months
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Baseline to 3 months
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Change in self-efficacy (MUSE)
기간: Baseline to 6 months
|
Change in score on MUSE scale from baseline to 6 months
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Baseline to 6 months
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Change in self-efficacy (MUSE)
기간: Baseline to 3 months
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Change in score on MUSE scale from baseline to 3 months
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Baseline to 3 months
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Change in self-efficacy (Self-Efficacy for Managing Chronic Disease)
기간: Baseline to 6 months
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Change in score on SEMCD scale from baseline to 6 months
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Baseline to 6 months
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Change in self-efficacy (Self-Efficacy for Managing Chronic Disease)
기간: Baseline to 3 months
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Change in score on SEMCD scale from baseline to 3 months
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Baseline to 3 months
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Change in chronic stress
기간: Baseline to 6 months
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Change in chronic stress from baseline to 6 months, as measured by salivary cortisol
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Baseline to 6 months
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Change in perceived stress
기간: Baseline to 6 months
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Change in score on 4-item version of Perceived Stress Scale from baseline to 6 months
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Baseline to 6 months
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Change in perceived stress
기간: Baseline to 3 months
|
Change in score on 4-item version of Perceived Stress Scale from baseline to 3 months
|
Baseline to 3 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Marie A Krousel-Wood, MD MSPH, Tulane University
- 연구 책임자: Erin M Peacock, PhD MPH, Tulane University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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