AzTrials
AzTrials

HypertensionNCT02846220

Promoting Medication Adherence Among Older Adults With Hypertension

A study testing Overcoming Immunity to Change health coaching in people with Hypertension, run by Tulane University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Hypertension
What is being tested?
Overcoming Immunity to Change health coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
Oct 2016to 30 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • Cognitive impairment
  • Enrollment in another clinical trial

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Tulane University

    New Orleans, Louisiana, 70112

Other trials in United States

About this study

Official title: 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).

Conditions
Hypertension
Being tested
Overcoming Immunity to Change health coaching
Keywords
Medication Adherence, Middle Aged 45-64, Aged 65-79, Aged, 80 and over
Medical subject headings
Hypertension, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Overcoming Immunity to Change health coachingBehavioural

Study groups in NCT02846220
Study groupRoleWhat they receive
Health coachingExperimentalTwo-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
Receives: Behavioral: Overcoming Immunity to Change health coaching
Usual careNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in medication adherence (PDC)

    Change in proportion of days covered (PDC) from baseline to 6 months

    Measured: Baseline to 6 months

Secondary outcomes (17)

  1. Change in medication adherence (MMAS-8)

    Change in MMAS-8 score from baseline to 6 months

    Measured: Baseline to 6 months

  2. Change in medication adherence (KWood-4)

    Change in KWood-4 score from baseline to 6 months

    Measured: Baseline to 6 months

  3. Change in medication adherence (MMAS-8)

    Change in MMAS-8 score from baseline to 3 months

    Measured: Baseline to 3 months

  4. Change in medication adherence (KWood-4)

    Change in KWood-4 score from baseline to 3 months

    Measured: Baseline to 3 months

  5. Change in proportion with low adherence (PDC)

    Change in proportion with low adherence (PDC<0.8) from baseline to 6 months

    Measured: Baseline to 6 months

  6. Change in proportion with low adherence (MMAS-8)

    Change in proportion with low adherence (MMAS-8<6) from baseline to 6 months

    Measured: Baseline to 6 months

  7. Change in proportion with low adherence (KWood-4)

    Change in proportion with low adherence (KWood-4>0) from baseline to 6 months

    Measured: Baseline to 6 months

  8. Change in proportion with low adherence (MMAS-8)

    Change in proportion with low adherence (MMAS-8<6) from baseline to 3 months

    Measured: Baseline to 3 months

  9. Change in proportion with low adherence (KWood-4)

    Change in proportion with low adherence (KWood-4>0) from baseline to 3 months

    Measured: Baseline to 3 months

  10. Change in systolic blood pressure

    Change in systolic blood pressure from baseline to 6 months

    Measured: Baseline to 6 months

  11. Change in diastolic blood pressure

    Change in diastolic blood pressure from baseline to 6 months

    Measured: Baseline to 6 months

  12. Change in systolic blood pressure

    Change in systolic blood pressure from baseline to 3 months (if available from insurance records)

    Measured: Baseline to 3 months

  13. Change in diastolic blood pressure

    Change in diastolic blood pressure from baseline to 3 months (if available from insurance records)

    Measured: Baseline to 3 months

  14. Change in proportion with controlled blood pressure

    Change in proportion with controlled blood pressure (SBP<140 \& DBP<90) from baseline to 6 months

    Measured: Baseline to 6 months

  15. Change in proportion with controlled blood pressure

    Change in proportion with controlled blood pressure (SBP<140 \& DBP<90) from baseline to 3 months

    Measured: Baseline to 3 months

  16. Change in health-related quality of life

    Change in health-related quality of life score (SF-36) from baseline to 6 months

    Measured: Baseline to 6 months

  17. Change in health-related quality of life

    Change in health-related quality of life score (SF-36) from baseline to 3 months

    Measured: Baseline to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2016 (estimated)
  2. Study startOct 2016
  3. Primary completion30 Dec 2019
  4. Study completion30 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02846220
Sponsor's protocol ID
735133
Status last verified
Oct 2020
First submitted
24 May 2016
Last updated
20 Oct 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Krousel-Wood M, Kegan R, Whelton PK, Lahey LL. Immunity-to-change: are hidden motives underlying patient nonadherence to chronic disease medications? Am J Med Sci. 2014 Aug;348(2):121-8. doi: 10.1097/MAJ.0000000000000310.

    PubMed 24978395

Questions about this trial

What is this clinical trial studying?

A study testing Overcoming Immunity to Change health coaching in people with Hypertension, run by Tulane University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in medication adherence (PDC) (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02846220, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in