An interventional study of Digital Outreach in CHF - Congestive Heart Failure, sponsored by Kaiser Permanente. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Other
The goal of the ADHERE-HF study is to evaluate whether care-embedded, operationally delivered digital outreach improves medication refill, adherence, and clinical outcomes among adults with heart failure who are overdue for a refill of an eligible guideline-directed medical therapy (GDMT) medication.
The main question it aims to answer is: Does digital outreach using interactive text messages or automated telephone calls increase short-term refill of overdue heart failure medications compared with usual care?
The study will evaluate the effectiveness of a digital outreach strategy delivered through existing health system communication channels. Members who have opted in to pharmacy text messaging will receive interactive text messages, while those who have not opted in will receive an interactive automated telephone call. The comparison group will receive usual care with no additional outreach.
Heart failure is a common chronic condition associated with hospitalization, impaired quality of life, and premature death. Guideline-directed medical therapy (GDMT) can reduce the risk of cardiovascular death and worsening heart failure, but patients must continue to refill and take these medications to receive their full benefit. Medication nonadherence remains common and contributes to a gap between the benefits observed in clinical trials and those achieved in routine care. The ADHERE-HF study is a pragmatic, prospective, open-label, individual-level randomized clinical trial designed to evaluate whether digital outreach improves refill of overdue GDMT medications among adults with heart failure. The study will compare a text-first digital outreach strategy with usual care and will be conducted through existing health system pharmacy operations.
Eligible members will be randomized in a 1:1 ratio to operationally conducted digital outreach or usual care. Randomization will be stratified by ejection fraction category and by whether the member has opted in to pharmacy text outreach at the time of randomization. Members assigned to digital outreach who have opted in to pharmacy text messaging will receive interactive two-way text messages. These messages notify members that they may be due for a medication refill and provide options to request mail-order delivery or pharmacy pickup. Responses indicating medication, cost, dosing, or other concerns may be referred to pharmacy staff for follow-up. Members assigned to digital outreach who have not opted in to pharmacy text messaging will receive an interactive automated telephone call. The call allows members to select among refill options using the telephone keypad. Members may request refill at their usual pharmacy, use or establish mail-order delivery, or transfer to a pharmacy representative for assistance. Members assigned to usual care will receive no additional outreach. All members will continue to receive routine pharmacy refill communications and other standard health system services. Members will remain assigned to their randomized strategy for 12 months. If any eligible GDMT medication becomes overdue during follow-up, members in the digital outreach group may receive additional outreach. Outreach modality will be based on each member's pharmacy text opt-in status at the time of each contact.
The primary outcome is refill, within 14 days of the outreach date, of at least one GDMT medication that was overdue at randomization. Secondary outcomes include refill within 28 days, the proportion of overdue medications refilled, time to first refill, mail-order fulfillment, medication adherence and persistence at 6 and 12 months, heart failure hospitalization, and all-cause mortality. All outcomes will be obtained from routinely collected, operationally available pharmacy dispensing, electronic health record, administrative, and digital communication data.
The study has no study-specific visits or any direct contact by the study team. This study is designed to generate care-embedded, actionable evidence within a learning health system by determining whether scalable digital outreach improves refill and adherence to guideline-directed heart failure medications and whether the strategy should be implemented more broadly.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 13,714 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Kaiser Permanente is the lead sponsor of 393 studies on the registry; 43 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Prescribed at least one eligible GDMT medication for ≥6 months:
Exclusion Criteria:
Participants will receive interactive text messages or automated phone calls encouraging refill of overdue heart failure medications.
Behavioral: Digital Outreach
Participants in this arm will receive usual care with no proactive outreach during the study period.
Participants assigned to this arm will receive digital outreach encouraging refill of overdue guideline-directed medical therapy (GDMT) medications for heart failure. Participants who have opted in to pharmacy text messaging at the time of outreach will receive interactive text messages. Participants who have not opted in to pharmacy text messaging will receive an interactive automated telephone call. Participants may receive additional outreach during the 12-month intervention period if another eligible GDMT medication becomes overdue.
Refill of at least one overdue GDMT medication (within 14 days)
Proportion of participants who refill at least one guideline-directed medical therapy (GDMT) medication for which they were overdue at randomization (index) based on pharmacy dispensing records.
Time frame: Within 14 days after outreach
Composite of heart failure hospitalization or all-cause death
Time to first occurrence of heart failure hospitalization or death from any cause.
Time frame: Up to 12 months after randomization
Time to first refill of an overdue GDMT medication
Time from outreach to refill of any GDMT medication for which the participant was overdue at randomization, measured using pharmacy dispensing records. Participants who do not refill will be censored at disenrollment, death, or 28 days after outreach.
Time frame: Up to 28 days after outreach
Refill of at least one overdue GDMT medication (within 28 days)
Proportion of participants who refill at least one GDMT medication for which they were overdue at randomization, based on pharmacy dispensing records.
Time frame: Within 28 days after outreach
Proportion of overdue GDMT medications refilled (within 14 days)
For each participant, the proportion of GDMT medications overdue at randomization that are refilled, determined from pharmacy dispensing records.
Time frame: Within 14 days after outreach
Proportion of overdue GDMT medications refilled (within 28 days)
For each participant, the proportion of GDMT medications overdue at randomization that are refilled, determined from pharmacy dispensing records.
Time frame: Within 28 days after outreach
Heart failure hospitalization
Time to first heart failure hospitalization.
Time frame: Up to 12 months after randomization
All-cause death
Time to death from any cause
Time frame: Up to 12 months after randomization
Recurrent heart failure hospitalizations
Total number of heart failure hospitalizations occurring during follow-up.
Time frame: Up to 12 months after randomization
Mail-order fulfillment
Proportion of participants who receive a mail-order dispense for at least one GDMT medication that was overdue at randomization.
Time frame: Within 14 days after outreach
GDMT adherence (proportion of days covered)
Adherence to GDMT measured as proportion of days covered (PDC). PDC will be calculated separately by GDMT class and overall across prescribed classes.
Time frame: At 6 months and 12 months after randomization
GDMT persistence
Persistence with GDMT therapy, defined as time to the first gap in medication supply exceeding 60 days. Persistence will be evaluated separately by GDMT class prescribed.
Time frame: At 6 months and 12 months after randomization
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.