Effect of the family-centered empowerment model on health status, functional independence, and post-implantation complications in older adults with cardiac implantable electronic devices: a quasi-experimental study

Cardiac implantable electronic devices (CIEDs) are increasingly used in older adults, but implantation may be followed by clinical complications and psychological symptoms that impair health status and functional independence. This study evaluated a nurse-led intervention based on the Family-Centered Empowerment Model (FCEM) in older adults with CIEDs. In this two-arm quasi-experimental study, 80 patients aged ≥ 60 years with newly implanted CIEDs and their primary family caregivers were recruited from two teaching hospitals in Tehran, Iran. Hospitals were allocated by coin toss to FCEM plus routine care ( n = 40) or routine care alone ( n = 40). The four-step FCEM intervention was delivered to each patient–caregiver dyad over three months through six biweekly contacts. Health status (EQ-5D-3 L), functional independence (Barthel Index), and clinical complications and psychological symptoms (researcher-developed checklist) were assessed after implantation and at three months. At three months, the intervention group had higher EQ-5D-3L index scores (0.75 ± 0.23 vs. 0.52 ± 0.22; adjusted difference 0.23, 95% CI: 0.13 to 0.33; p < 0.001) and Barthel Index scores (87.00 ± 14.62 vs. 74.38 ± 17.13; adjusted difference 12.72, 95% CI: 5.77 to 19.51; p < 0.001), and lower adjusted risks of pain (RR = 0.58, 95% CI: 0.37–0.89; p = 0.014) and self-reported depressive or grief symptoms (RR = 0.50, 95% CI: 0.33–0.77; p = 0.002). Rhythm disturbance and palpitations (RR = 1.81, 95% CI: 0.96–3.41; p = 0.069) and dyspnea or pulmonary problems (RR = 0.60, 95% CI: 0.30–1.18; p = 0.140) did not differ significantly. In this non-randomized study with one hospital per arm, the FCEM-based intervention was associated with better health status and functional independence and with less frequent pain and depressive or grief symptoms. Because the intervention cannot be separated from the treating center, these findings are preliminary and require confirmation in multicenter randomized trials. This study was not prospectively registered. It was registered retrospectively in ClinicalTrials.gov under the number NCT07857915 on 09/29/2026. The study was a non-randomized, quasi-experimental evaluation in which the hospital, rather than the individual participant, was the unit of allocation. The study was conducted as part of a master’s thesis project and received institutional ethical approval from Shahid Beheshti University of Medical Sciences (IR.SBMU.PHARMACY.REC.1402.120). Prospective registration was not undertaken at the design stage because registration could not be obtained through the Iranian Registry of Clinical Trials (IRCT). To enhance transparency despite the absence of prospective public registration, an investigator-developed study protocol was prepared before the initiation of the study and retained by the research team. The protocol specified the study procedures, intervention, outcomes, and planned analytical approach. The conduct and reporting of the study were subsequently compared with this pre-existing protocol. Where any substantive departure from the protocol occurred, the corresponding methodological change was identified explicitly in the Methods as a protocol deviation, together with an explanation where appropriate. This approach was adopted to provide readers with a transparent account of any departures from the study plan despite the absence of a publicly time-stamped registry record.