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<article xmlns:xlink="http://www.w3.org/1999/xlink" article-type="letter" dtd-version="2.0">
  <front>
    <journal-meta>
      <journal-id journal-id-type="publisher-id">ResProt</journal-id>
      <journal-id journal-id-type="nlm-ta">JMIR Res Protoc</journal-id>
      <journal-title>JMIR Research Protocols</journal-title>
      <issn pub-type="epub">1929-0748</issn>
      <publisher>
        <publisher-name>JMIR Publications</publisher-name>
        <publisher-loc>Toronto, Canada</publisher-loc>
      </publisher>
    </journal-meta>
    <article-meta>
      <article-id pub-id-type="publisher-id">v15i1e93636</article-id>
      <article-id pub-id-type="pmid">42102381</article-id>
      <article-id pub-id-type="doi">10.2196/93636</article-id>
      <article-categories>
        <subj-group subj-group-type="heading">
          <subject>Letter to the Editor</subject>
        </subj-group>
        <subj-group subj-group-type="article-type">
          <subject>Letter to the Editor</subject>
        </subj-group>
      </article-categories>
      <title-group>
        <article-title>Posttrial Withdrawal Ethics in the Healthy Ageing Ecosystem for People With Dementia (HAAL) Study</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="editor">
          <name>
            <surname>Nedunchezhiyan</surname>
            <given-names>Surya</given-names>
          </name>
        </contrib>
      </contrib-group>
      <contrib-group>
        <contrib id="contrib1" contrib-type="author" corresp="yes">
          <name name-style="western">
            <surname>Johny</surname>
            <given-names>Praisewin</given-names>
          </name>
          <degrees>MSW, MBA</degrees>
          <xref rid="aff1" ref-type="aff">1</xref>
          <address>
            <institution>Rajagiri College of Social Sciences (Autonomous)</institution>
            <addr-line>Rajagiri P.O</addr-line>
            <addr-line>Kalamassery</addr-line>
            <addr-line>Cochin, Kerala, 683104</addr-line>
            <country>India</country>
            <phone>91 6238981847</phone>
            <email>praisewinjohn@gmail.com</email>
          </address>
          <ext-link ext-link-type="orcid">https://orcid.org/0000-0002-7788-4524</ext-link>
        </contrib>
        <contrib id="contrib2" contrib-type="author">
          <name name-style="western">
            <surname>KR</surname>
            <given-names>Anish</given-names>
          </name>
          <degrees>PhD</degrees>
          <xref rid="aff1" ref-type="aff">1</xref>
          <ext-link ext-link-type="orcid">https://orcid.org/0000-0002-3445-564X</ext-link>
        </contrib>
      </contrib-group>
      <aff id="aff1">
        <label>1</label>
        <institution>Rajagiri College of Social Sciences (Autonomous)</institution>
        <addr-line>Cochin, Kerala</addr-line>
        <country>India</country>
      </aff>
      <author-notes>
        <corresp>Corresponding Author: Praisewin Johny <email>praisewinjohn@gmail.com</email></corresp>
      </author-notes>
      <pub-date pub-type="collection">
        <year>2026</year>
      </pub-date>
      <pub-date pub-type="epub">
        <day>8</day>
        <month>5</month>
        <year>2026</year>
      </pub-date>
      <volume>15</volume>
      <elocation-id>e93636</elocation-id>
      <history>
        <date date-type="received">
          <day>17</day>
          <month>2</month>
          <year>2026</year>
        </date>
        <date date-type="accepted">
          <day>17</day>
          <month>3</month>
          <year>2026</year>
        </date>
      </history>
      <copyright-statement>©Praisewin Johny, Anish KR. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 08.05.2026.</copyright-statement>
      <copyright-year>2026</copyright-year>
      <license license-type="open-access" xlink:href="https://creativecommons.org/licenses/by/4.0/">
        <p>This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.</p>
      </license>
      <self-uri xlink:href="https://www.researchprotocols.org/2026/1/e93636" xlink:type="simple"/>
      <related-article related-article-type="commentary-article" id="v14i1e59860" ext-link-type="doi" xlink:href="10.2196/59860" vol="14" page="e59860" xlink:type="simple">https://www.researchprotocols.org/2025/1/e59860/</related-article>
      <related-article related-article-type="commentary-article" id="v15i1e95516" ext-link-type="doi" xlink:href="10.2196/95516" vol="15" page="e95516" xlink:type="simple">https://www.researchprotocols.org/2026/1/e95516/</related-article>
      <kwd-group>
        <kwd>older people</kwd>
        <kwd>dementia</kwd>
        <kwd>dashboard</kwd>
        <kwd>technology for older adults</kwd>
        <kwd>digital health</kwd>
        <kwd>eHealth</kwd>
        <kwd>innovation in health care</kwd>
      </kwd-group>
    </article-meta>
  </front>
  <body>
    <sec>
      <title>Letter to the Editor</title>
      <p>This letter addresses the protocol by Amabili et al [<xref ref-type="bibr" rid="ref1">1</xref>] for the Healthy Ageing Ecosystem for People with Dementia (HAAL) study. While the rigorous user-centered design is commendable, an ethical concern about posttrial responsibilities warrants discussion in assistive technology research.</p>
      <p>The protocol describes a 3-month deployment of an integrated smart home ecosystem, followed by system removal at the final evaluation [<xref ref-type="bibr" rid="ref1">1</xref>]. Participants received training, adapted their care routines around the technology, and showed reduced stress in preliminary findings. However, the protocol contains no explicit provisions for posttrial access or management of dependency effects when beneficial interventions are withdrawn.</p>
      <p>This raises a critical question: What are researchers’ responsibilities to participants who integrate assistive technologies into daily life, particularly vulnerable older adults with progressive cognitive decline and their already-burdened caregivers?</p>
      <p>International research ethics frameworks recognize that responsibilities extend beyond intervention periods. The Declaration of Helsinki requires planning for continued access to beneficial interventions [<xref ref-type="bibr" rid="ref2">2</xref>]. Clinical trial withdrawal studies document that stopping beneficial interventions causes distress for participants and creates tension between beneficence and research constraints [<xref ref-type="bibr" rid="ref3">3</xref>]. When assistive technologies become integrated into daily care routines and are then removed, loss of perceived independence or safety constitutes an ethical problem [<xref ref-type="bibr" rid="ref4">4</xref>].</p>
      <p>For people with dementia and their caregivers, this concern carries particular weight. Caregivers may restructure routines around monitoring alerts and experience genuine stress relief. Removing supports after 3 months risks reversing benefits and creating new harms: increased anxiety, perceived safety loss, and care pattern disruption.</p>
      <p>Assistive technology feasibility studies should adopt posttrial continuity and transition protocols including (1) explicit disclosure about posttrial plans in consent documents; (2) gradual tapering rather than abrupt removal; (3) transition support periods with counseling and alternative resources; (4) continuation pathways where feasible; and (5) systematic assessment of withdrawal impacts, reported transparently.</p>
      <p>This critique does not suggest the HAAL study was unethical; feasibility pilots routinely involve temporary deployment and participants were informed [<xref ref-type="bibr" rid="ref1">1</xref>]. Rather, as our field matures, frameworks bridging clinical research ethics (emphasizing posttrial access) with technology research (treating devices as temporary interventions) must be developed [<xref ref-type="bibr" rid="ref5">5</xref>].</p>
      <p>The HAAL protocol represents important innovation. Building on this foundation, our community should address the ethical gap between validating assistive technologies and responsibly managing their withdrawal from participants’ lives.</p>
    </sec>
  </body>
  <back>
    <app-group/>
    <glossary>
      <title>Abbreviations</title>
      <def-list>
        <def-item>
          <term id="abb1">HAAL</term>
          <def>
            <p>Healthy Ageing Ecosystem for People with Dementia</p>
          </def>
        </def-item>
      </def-list>
    </glossary>
    <fn-group>
      <fn fn-type="conflict">
        <p>None declared.</p>
      </fn>
    </fn-group>
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</article>
